A patient who has had a lumpectomy with positive margins as part of their treatment for a current DCIS diagnosis is eligible (post-excision mammogram required at enrollment to establish a new baseline)
Surgical margins must be clear of invasive carcinoma; if there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended; if further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumor bed is delivered; in situ lobular disease at the margin is acceptable
For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist; if pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
For patients who undergo mastectomy, the margins must be free of residual gross tumor; (patients with microscopic positive margins are eligible as long as post-mastectomy radiation therapy [RT] of the chest wall will be administered)
The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days
Completely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative margins; patients may not have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
Evidence that tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins)
Must have completed definitive resection of primary tumor\r\n* Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however patients with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy; patients with margins positive for lobular carcinoma in situ (LCIS) are eligible\r\n* Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable\r\n* Sentinel node biopsy either pre or post neoadjuvant chemotherapy (i.e. at the time of definitive surgery) are allowed; axillary dissection is encouraged in patients with lymph node involvement, but is not mandatory
No invasive cancer at the surgical margins
For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist; additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor
Patients with microscopic positive margins after definitive surgery
Completed adequate breast surgery defined as:\r\n* The inked margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ with the exception of the posterior margin if this margin is the pectoralis major fascia or the anterior margin if this is the dermis; patients with resection margins positive for lobular carcinoma in situ are eligible\r\n* Patients with breast conservation must have adjuvant radiotherapy; patients having mastectomy may have adjuvant radiotherapy according to local policy and/or international guidelines
Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
Margins of the resected specimen or re-excision specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the pathologist\r\n* Notes: Additional operative procedures may be performed to obtain clear margins; focally positive margins are acceptable based on technical feasibility of additional surgery and/or the potential for benefit with further surgery based on the extent and location of the positive margin (eg, focally positive deep margin at the pectoralis fascia); also, patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection
Microscopic positive margins after definitive surgery\r\n* Note: Patients with microscopically focally positive margins following lumpectomy or mastectomy are not excluded if re-excision is not technically feasible and/or there is no benefit to further surgery based on the extent and location of the positive margin
Tumor is deemed to be resectable with negative margins by conventional surgical standards
Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection
If there are 3 or more attempts by the surgeon to clear margins, patient is not eligible for study
Patients will have close margins
Positive margins after definitive surgery
Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients; a minimum of 4 weeks should elapse between any surgery and treatment on study; however, high-risk pathologic features should be present, such as positive margins, positive lymphadenopathy, perineural or angiolymphatic invasion
Subjects must have a histologically confirmed pancreatic adenocarcinoma that has had an R0 (negative margins) or R1 (microscopically positive margins) resection
Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted.
Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible).
Inability to localise surgical bed on CT scans and/or surgical margins (cm) not known
One or more high risk features including: seminal vesicle invasion, extracapsular extension, positive margins, or a PSA post surgery between 0.2 and < 2.0
Must have undergone gross total resection of the primary tumor with curative intent within the past 8 weeks with surgical pathology demonstrating >= 1 of the following criteria for \intermediate\ risk of recurrence:\r\n* Perineural invasion\r\n* Lymphovascular invasion\r\n* Single lymph node > 3 cm or at least 2 nodes without evidence of extracapsular extension\r\n* Close margins defined as < 5 mm but not frankly positive (in the case of ambiguous, controversial, or superseded margins, final clinical assessment regarding margin status will prevail)\r\n* Pathologically confirmed T3 or T4 primary tumor.
INCLUSION - TREATMENT: Fibrotic area of prior tumor located at least 3 mm away from surgical margins
The primary tumor must be considered resectable by RP with gross negative margins as determined by a urologist. (Applicable to cohorts A and B1 only)
Has undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins.
Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia
Multicentric cancer in the ipsilateral breast as diagnosed by clinical examination, imaging, or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
Primary tumor excised by radical inguinal orchiectomy and pathology consistent with pure seminoma with negative surgical margins
Surgical treatment of the breast with lumpectomy plus (+) clinical target volume (CTV) margin up to 65 cc's or 5 cm in maximum dimension with histologically confirmed margins free of tumor (negative margins defined as no tumor on ink in all directions); re-excision of surgical margins is permitted
Pathologic T1 or T2 disease, resected with negative margins (>= 2mm)
Presence of close (< 2 mm) or positive margins
Focally positive surgical margins are permitted
Patients treated with simple cystectomy with macroscopically negative margins are eligible for this study
All tumors (invasive and non-invasive disease) must be excised with a minimum margin width of >= 2 mm; re-excision of surgical margins is permitted; focally close (< 2 mm) or positive (tumor cells at the inked edge of the specimen) margins determined to be at an anatomic boundary of resection by the surgeon, such as posterior fascia for posterior margins or skin for anterior margins, are also acceptable
The patient must be enrolled on the study within 42 days following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure)
Surgical margins that cannot be microscopically assessed or are positive at pathological evaluation; a focally positive margin determined to be at an anatomic boundary of resection by the surgeon, such as posterior fascia for posterior margins and skin for anterior margins, is also acceptable; if surgical margins are rendered free of disease by re-excision, the patient is eligible
Must have a lumpectomy performed, with documented negative surgical margins by 0.2 cm or more. If re-excision results in negative surgical margins 0.2 cm or more, patient is eligible.
If markers or clips were placed at the time of surgery, patient must be able to start treatment within 12 weeks after lumpectomy or re-excision for adequate margins.
Surgical treatment of the breast must have been lumpectomy; the margins of the resected specimen must be histologically free of tumor (DCIS and invasive); reexcision of surgical margins is permitted
Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation; (if surgical margins are rendered free of disease by reexcision, the patient is eligible)
Histologically positive margins
Negative inked histologic margins of lumpectomy (no invasive cells at margin) or negative re-excision specimen to be confirmed prior to radiation
The subject must have a complete removal of the primary HNSCC lesion with negative gross and microscopic margins; documentation of margins by frozen sections at surgery is recommended; patients who have already had surgery and have available banked tumor samples can be enrolled AFTER surgery
Surgical treatment of the breast must have been lumpectomy; the margins of the resected specimen must be histologically free of tumor (negative surgical margins per National Surgical Adjuvant Breast and Bowel Project [NSABP] criteria)
Surgical margins that cannot be microscopically assessed or that are positive
Patients with positive or close (< 3 mm) resection margins
Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
Patients with an HGG that was completely resected with good margins
Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy (with or without planned postmastectomy radiation); patients must have clear margins from both invasive breast cancer and DCIS (as per local institutional guidelines); lobular carcinoma in situ (LCIS) at the margins is allowed
Patients at initial presentation of melanoma must undergo an adequate wide excision of the primary lesion, if present; patients with previously diagnosed melanoma must have had all current disease resected with pathologically negative margins and must have no evidence of disease at the primary site or must undergo re-resection of the primary site; a full lymphadenectomy meeting the criteria outlined is required for all node-positive patients including those with positive sentinel nodes; patients with recurrent disease who have had a prior complete lymphadenectomy fulfill this requirement as long as all recurrent disease has been resected; for all patients, all disease must have been resected with negative pathological margins and no clinical, radiologic, or pathological evidence of any incompletely resected melanoma; patients must be registered within 98 days of the last surgery performed to render the patient free of disease
Positive surgical margins are permitted if the surgeon confirms complete resection of gross metastatic disease, and post-operative scans are negative
Patients must have undergone a full surgical resection (radical nephrectomy or partial nephrectomy), including removal of all clinically positive nodes; surgical margins must be negative; patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive); patients must plan to start study drug within 84 days after the date of full surgical resection; patients must have recovered from any surgical related complications
Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration with surgical pathology demonstrating one or more of the following “intermediate” risk factors:\r\n* Perineural invasion\r\n* Lymphovascular invasion\r\n* Single lymph node > 3 cm or >= 2 lymph nodes (all < 6 cm) (no extracapsular extension)\r\n* Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins; similarly, patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible; for questions or ambiguities about an individual case, contact Dr. Machtay and/or Dr. Holsinger prior to enrolling the patient\r\n* Pathologically confirmed T3 or T4a primary tumor; for questions or ambiguities about an individual case, contact Dr. Machtay and/or Dr. Holsinger prior to enrolling the patient\r\n* T2 oral cavity cancer with > 5 mm depth of invasion
Per the operative and/or pathology report, positive margin(s) (defined as tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery; note: patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible; for questions or ambiguities about an individual case, contact Dr. Machtay and/or Dr. Holsinger prior to enrolling the patient
One of the following pathologic T-classifications: pT2 or pT3\r\n* Patients with positive surgical margins are eligible
Histologic diagnosis of resected stages IIIB/IIIC/IV melanoma, with no evidence of disease clinically and radiologically, and negative surgical margins; all melanomas regardless of primary site of disease will be allowed
Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
Negative histologic margins of partial mastectomy or re-excision specimen; margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge
Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation
The final margins of the resected specimen must be histologically free of tumor
Surgical margins that cannot be microscopically assessed or that are positive
All tumor removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy)\r\n* NOTE: management of axillary lymph nodes is up to the treating provider; however, all surgical margins should be clear of invasive cancer or DCIS (i.e., no tumor on ink); the local pathologist must document negative margins of resection in the pathology report; if all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed; likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed
Patients must have pathological Gleason (pG) sum 8-10; or pG sum 7 and either pT3 or R1 disease (i.e. positive margins)
Must have completed definitive resection of primary tumor. The most recent surgery for breast cancer must have been completed at least 14 days prior (but no more than 84 days prior) to study registration. NOTE: Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however participants with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy. Participants with margins positive for lobular carcinoma in situ (LCIS) are eligible. Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable.
Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer, cervical intraepithelial neoplasia (CIN) II, CIN III or adenocarcinoma-in-situ; (a negative margin is defined as no invasive cancer within 1.0 mm of both the endocervical and ectocervical margins and no adenocarcinoma in situ [AIS] or CIN II or CIN III at the inked or cauterized margin; one repeat cone and ECC permitted)
Cone margins or ECC specimen positive for invasive cancer, CIN II, CIN III or adenocarcinoma-in-situ (one repeat cone permitted)
Gross residual tumor or positive margins after surgery that is un-excised, as radiation dose in the study will be limited to 60 Gy.
All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection\r\n* All margins should be clear of invasive cancer or DCIS (i.e. no tumor on ink); the local pathologist must document negative margins of resection in the pathology report; if all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed; likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed; radiation therapy to the conserved breast is required
Patients must have clear margins after wide local excision; patients with nodes that are palpable or detectable on radiologic imaging must have an adequate lymphadenectomy
Negative margins after lumpectomy (re-excision for initial positive margins is allowed-negative margins defined as >= 2 mm clear of tumor in all directions); histological negative margins closer than 2 mm are permitted in the circumstance where the margin of excision is limited by adjacent tissues such as pectoral muscle or skin, but in the opinion of the surgeon and radiation oncologist an oncologically adequate excision was achieved
Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded
Close (<3mm) or positive surgical margins on microscopic evaluation with no gross residual tumor
Have pathology-proven complete removal of all primary and liver metastatic CRC lesions. Subjects with positive margins will not be eligible for the study.
Negative surgical margins, defined as no margin-labeling ink on tumor cells from margin evaluation
Histologic proof of presence of residual tumor in liver explants and /or positive resection margins
Negative inked histologic margins from mastectomy pathology (no invasive cells at margin)
Repeat surgeries for oncologic reasons (positive margins)
pT1 breast cancer, excised with negative margins\r\n* Low risk-pTis breast cancer, excised with negative margins\r\n* Criteria for low risk-pTis:\r\n** Screen-detected\r\n** Low to intermediate nuclear grade\r\n** =< 2.5 cm in size\r\n** Resected with negative margins at >= 3 mm
Breast-conserving surgery with surgical excision of all gross disease with negative surgical margins (with the exception of a positive margin at skin and/or fascia where no more breast tissue can be removed) or mastectomy surgery with no gross residual disease
Tumor distance, including tumor free margins, should not be more than 40mm from the rectal wall.
New diagnosis if a previous breast cancer patient with negative surgical margins
Positive surgical margins
Positive surgical margins, or
Undergoing a second lumpectomy procedure because of positive margins in a previous surgery prior to entering this study.
Subjects undergoing a second surgery because they had positive margins in a previous surgery.
Women with positive margins after primary surgery
Women presenting after excision with positive margins are eligible; Ki-67, cyclooxygenase 2 (Cox-2), cyclin-dependent kinase inhibitor 2A (P-16), expression in immediately adjacent tissue is similar to what is found in DCIS\r\n* Note: Positive margins are defined as DCIS present at the inked margin or DCIS < 1 mm from the margin
Clinical T2-T4c, any N, M0 invasive breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to complete excision of the tumor in the breast and the lymph node\r\nPrimary tumor must be:\r\n* Palpable\r\n* Its largest tumor diameter is > 2.0 cm by physical examination or by radiological assessment\r\n* Bi-dimensional measurement by tape, ruler or caliper technique must be provided\r\n** Note:\r\n*** Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are not eligible\r\n*** Patients with multi-focal breast cancer (defined as more than one lesion of invasive breast cancer in the same breast separated from the dominant breast lesion by less than 5 cm of radiologically normal breast tissue) are eligible; if the other lesions have been biopsied (biopsy not required) they must meet the estrogen receptor/human epidermal growth factor receptor 2 (ER/HER2) eligibility requirements; research biopsies and Ki67 assessment and radiological measures are to be performed on the dominant breast lesion
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d’orange without erythema)
Overall geometry (eg, breast size if intact breast) precludes the ability to achieve dosimetric requirements \r\n* Note: Set-up devices for breast positioning are permitted
Patients must have the clinical diagnosis of inflammatory breast cancer as evidenced by the onset of signs and symptoms noted below within a 6 month time-period:\r\n* Erythema of the breast\r\n* Edema of the skin of the breast\r\n* Enlargement of the breast
Patients with inflammatory breast cancer are eligible if they meet both of the following criteria:\r\n* Patient has an underlying, clinically palpable breast mass of at least 2 cm, AND\r\n* A corresponding lesion is visualized on mammogram or ultrasound
Breast size adequate for safe cryoablation
Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC) 4. Presence of multifocal and/or multicentric in breast cancer 5. Presence of multifocal calcifications 6. Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer
PIK3CA MUTANT AND WILD TYPE COHORT (closed 03/17/2016): Evidence of inflammatory cancer (clinical presentation of skin erythema involving more than one third of the breast or pathological evidence of dermal lymphatic involvement)
FNA alone to diagnose the breast cancer.
Healthy women age 35 - 75 years with either heterogeneously dense (C) or extremely dense (D), breast tissue on 2D mammography, based on American College of Radiology (ACR) Breast Imaging-Reporting and Data System (BI-RADS©) fifth edition classification) in either breast within 3 months prior to randomization. Mammogram with BI-RADS final assessment category 1 or 2 (negative or benign findings).
For patients who have undergone lumpectomy, there are no breast size limitations
Must be proceeding with breast/chest wall and nodal radiation therapy including internal mammary node treatment
Patients must meet one of the following criteria:\r\n* Pre-pathology cohort: Patient has new diagnosis of breast cancer and has elected BCS; these patients must be consented prior to the scheduled BCS with precision breast IORT; BCS (either primary breast surgery or re-excision) will occur one same date as precision breast IORT\r\n* Post-pathology cohort: Patient was previously treated for breast cancer with BCS; precision breast IORT will occur as a separate procedure within 30 days of breast surgery; these patients should be consented after they have completed the initial excision and histological confirmation of eligibility
Breast cancer that involves the skin or chest wall
For patients in the post-pathology stratification, precision breast IORT must be delivered within 30 days of the last breast cancer surgery (not axillary)
Note: Multicentric breast cancer and Paget's disease of the nipple are permitted.
Breast cancer:\r\n* Patients inappropriate for standard breast conservation therapy (multicentric disease, inability to achieve clear margins)\r\n* Male patients with breast cancer\r\n* Autoimmune disorders, including systemic lupus erythematosus (SLE), scleroderma, etc\r\n* Distant metastases
Presence of a clip in the primary breast cancer
Multicentric breast cancer, defined as discontiguous tumors separated by at least 5 cm of uninvolved tissue or discontiguous tumors that are located within separate breast quadrants either clinical or mammographically
Multifocal breast cancer, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5 cm, or within the same breast quadrant
Histologically confirmed breast cancer (infiltrating ductal or lobular breast carcinoma) with evidence of measurable metastatic disease; metastatic disease must be biopsy proven\r\n* Since histologic type, lymphatic permeation, blood vessel invasion, and degree of anaplasia may be prognostic variables, appropriate slides of the primary lesion will be requested for future review; HER2, estrogen, and progesterone receptor positivity will be recorded
Patients must have an accessible lesion in the breast/chest wall/axilla which has not been previously thermally ablated; prior breast irradiation is acceptable if the lesion has recurred or grown following radiation
Pathologically confirmed DCIS of the breast
Confirmed diagnosis of inflammatory breast cancer according to international consensus criteria: (1) onset: rapid onset of breast erythema, edema, and/or peau d’orange, and/or warm breast, with or without an underlying breast mass (2) duration: history of such findings no more than 6 months (3) extent: erythema occupying at least 1/3 of whole breast (4) pathology: pathologic confirmation of invasive carcinoma
Women must agree not to breast feed while on study
Breast cancer suitable for mandatory baseline core biopsy
(For Cohort A) Archived tissue available pre-screening to confirm FR alpha+ breast cancer. (For Cohort B) ·Confirmed FRalpha+ breast cancer defined as high FRalpha expression: >= 75% of cells having >= 1+ expression, or moderate FRalpha expression: 25%-74% of cells with >= 1+ expression
Excisional biopsy or lumpectomy for the current breast cancer
Subjects may not have had prior systemic chemotherapy regimens administered for treatment of their current breast cancer; however, studies (window studies, for example) that are deemed non-therapeutic, including those that utilize agents that are not Food and Drug Administration (FDA) approved for the treatment of the patient’s current breast cancer, are permitted
Tumor must be confined to either the breast or to the breast and ipsilateral axilla (Note: subjects with multifocal/multicentric tumors are eligible). Subject must have (according to TNM 7th edition rules):
Breast size B cup or larger, to allow for IORT procedure
Multifocal disease within the breast
Has confirmed inflammatory breast cancer by using international consensus criteria:\r\n* Onset: Rapid onset of breast erythema, edema and/or peau d’orange, and/or warm breast, with/without an underlying breast mass.\r\n* Duration: History of such findings no more than 6 months.\r\n* Extent: Erythema occupying at least 1/3 of whole breast.\r\n* Pathology: Pathologic confirmation of invasive carcinoma.
Distant metastasis that involves occurrence of breast cancer outside of locoregional breast and lymph nodes area.
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d’orange without erythema)
Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
Patients must have histologically or cytologically confirmed stage IV breast carcinoma with a previous clinical diagnosis of IBC based on the presence of inflammatory changes in the involved breast, such as diffuse erythema and edema (peau d’orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis
Patients must have invasive breast cancer (IBC), confirmed according to international consensus criteria:\r\n* Onset: Rapid onset of breast erythema, edema, and/or peau d’orange, and/or warm breast, with or without an underlying breast mass\r\n* Duration: History of such findings no more than 6 months\r\n* Extent: Erythema occupying at least 1/3 of whole breast\r\n* Pathology: Pathologic confirmation of invasive carcinoma
Pregnant or need to breast feed during the study period
For LY3300054 + abemaciclib in HR+, HER- breast cancer:
Family history: one or more close blood relative with ovarian carcinoma at any age or breast cancer age 50 or younger or two relatives with breast, pancreatic or prostate cancer (Gleason 7 or higher) at any age, or patients with Ashkenazi Jewish ancestry; however, patients with previously identified genetic aberrations that are associated with homologous recombination deficiency (HRD) will be eligible even in the absence of family history [e.g. somatic BRCA mutation, Fanconi anemia gene, ATM or RAD51 mutations]
Patients may not be on an inhibitor of breast cancer resistance protein (BCRP)\r\n* NOTE: AZD1775 is an inhibitor of breast cancer resistance protein (BCRP); the use of statins including atorvastatin which are substrates for BCRP are therefore prohibited and patients should be moved on to non-BCRP alternatives
localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy;
Presence of an infection including ulcerations and fungal infections in the breast to be studied
Prior radiation to the breast or chest wall
Resectable/operable or potentially resectable/operable breast cancer as determined by the treating surgical oncologist
Disease that cannot be measured and/or accurately followed by mammogram and/or breast ultrasound and/or dedicated breast MRI
Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric disease preventing resection through a single incision, no pregnant women, and no comorbid conditions precluding surgery)
Outside breast imaging will be reviewed at Duke to confirm that findings are consistent with trial eligibility
Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
Outside breast imaging will be reviewed at Duke to confirm findings are consistent with trial eligibility
Breast implant in the breast to be treated with stereotactic body radiation therapy (SBRT)
Has histological confirmation of HER2 normal breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d’orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis of inflammatory breast cancer regardless estrogen receptor (ER)/progesterone receptor (PR) status; OR has histological confirmation of triple negative breast carcinoma (HER2 normal, ER/PR < 10%) without clinical diagnosis of IBC
Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis
Patients with synchronous bilateral breast cancers who will be treated with radiotherapy to each breast are eligible, provided such treatment can be performed in a manner that avoids overlap between treatment fields; both sides may be treated with accelerated partial breast irradiation (APBI) if the pathologic eligibility criteria are met for both tumors, or only one side may be treated with APBI if the criteria are met for only one tumor
Patients with a history of prior breast cancer in the opposite breast are eligible as long as treatment can be performed without overlapping any prior radiation therapy (RT) fields
Suspicious residual microcalcifications on mammography of either breast, unless negative for malignancy on pathology.
Breast feeding (if lactating, must agree not to breast feed while taking pomalidomide)
Unifocal or multifocal (confined to one quadrant, lesions less than 4 cm apart) breast cancer (1 or 2 foci which can be encompassed by one lumpectomy)
Evidence of suspicious microcalcifications in the breast prior to the start of radiation
Patients with proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
Patients with a breast technically unsatisfactory for radiation therapy
Subareolar location (cancer is directly and completely under the nipple/areolar complex) of breast abnormality.
Prior radiation to the breast or chest wall
Previous breast surgery with the exception of biopsy
Transporter studies (in vitro) have shown that AZD1775 is an inhibitor of breast cancer resistance protein (BCRP)
The presence of gross skin invasion/ulceration by the breast cancer, or inflammatory changes with skin edema AND erythema; Note: Paget’s disease is permitted
Evidence of T4 disease (e.g., involvement of the chest wall, skin, dermal lymphatics, or inflammatory breast cancer)
Breast tumor must be >= 1.5 cm in maximum diameter by clinical or any radiologic measurement, if node negative; if node is positive by biopsy, study participant will be eligible regardless of the size of the breast primary; in case of inflammatory breast cancer, the extent of inflammation/erythema can be used as measurable lesion
Paget’s disease of the breast
FNA alone to diagnose the breast cancer
Centrally assessed Ki-67, pRB, and Cyclin D1 status assessed preferably on post-neoadjuvant residual invasive disease of the breast, or if not possible, of residual nodal invasion or core biopsy. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable.
Uncommon or rare subtypes of breast cancer.
Patients who wish to breast-feed during treatment
Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
Unsatisfactory breast for HG-PBI as determined by the treating physician; for example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, treatment with HG-PBI is technically problematic
Time between final definitive breast procedure to HG-PBI simulation is greater than 8 weeks
If multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision
Miller-Payne response in the breast of 0-25.
Alternatively, if Miller-Payne or RCB grading is not available, the patient will be eligible if the pathology report indicates that the area of residual invasive disease in the breast measures at least 2 cm following preoperative therapy. The presence of DCIS without invasion does not qualify as residual disease in the breast.
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d’orange without erythema)
Surgical treatment of the breast must have been lumpectomy
Paget’s disease of the breast
Normal mammogram of the contralateral breast within the past 12 months, defined as no new suspicious calcifications or other abnormal findings warranting a breast biopsy
Women must agree not to breast feed
PHASE II: Patients must have the clinical diagnosis of inflammatory breast cancer as evidenced by the onset of signs and symptoms noted below within a 6 month time-period:\r\n* Erythema of the breast\r\n* Edema of the skin of the breast\r\n* Enlargement of the breast
Breast > 800 grams or < 100 grams in predicted weight; “breast” includes the breast tissue and in cases where the patient already has cosmetic breast implants, the additional breast implant mass; the sum total must be > 100 g and < 800 g
History of radiation to the chest wall or breast being studied
Residual invasive disease in the breast measuring at least 2 cm. The presence of DCIS without invasion does not qualify as residual disease in the breast.
Partial breast irradiation must be scheduled to begin less than 71 days from the last breast surgical procedure
Patients with squamous or sarcomas of the breast
Patients must have the clinical diagnosis of inflammatory breast cancer as evidenced by the onset of all signs and symptoms noted below within a 6 month time-period:\r\n* Erythema of the breast\r\n* Edema of the skin of the breast\r\n* Enlargement of the breast
Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
Participants must have completed definitive breast surgery (mastectomy or breast-conserving) +/- reconstructive surgery with referral for definitive chest wall radiation therapy; patients with breast reconstruction are eligible if it determined by the referring or treating radiation oncologist that plan would be suboptimal without manipulation of breast implants; for patients without reconstruction, they must meet eligibility by having unfavorable cardiac anatomy defined as >= 5% of the heart receives >= 20 Gy and/or left anterior descending (LAD) receives >= 20 Gy with conventional planning; participants do not need to have measurable disease; most patients will not have measurable disease at the time of treatment
Evidence of suspicious microcalcifications in the breast prior to start of radiation
Patients with multicentric gross disease defined as tumors in different quadrants of the breast or tumor separated by at least 4 cm or other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy or biopsy
Final criteria for eligibility established after simulation: the tumor bed can be readily visualized on simulation computed tomography (CT) and is localized to one quadrant or region of the breast that is amenable to partial breast irradiation
History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
Patient is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the study, because of the potential for serious adverse reactions in nursing infants from vorinostat, breast feeding must be discontinued for the duration of therapy with vorinostat
Clinical diagnosis of IBC (presence of inflammatory changes in the involved breast, including diffuse erythema, heat, ridging, and peau d'orange)
Have histological confirmation of breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d’orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required at diagnosis
Subjects unfit for breast and/or axillary surgery (complete fixation of tumor, skin infiltration, erythema of the breast, and/or ulceration)
Pregnant or intend to become pregnant, breastfeeding or intend to breast-feed during this study
Evidence of inflammatory cancer (clinical presentation of skin erythema involving more than one third of the breast or pathological evidence of dermal lymphatic involvement)
Multicentric breast cancer (two foci of known cancer in the breast separated by greater than 5 cm, or in separate quadrants
Breast cancer metastatic to the pleura that extends outside of the pleura requiring immediate therapy
Primary breast cancer that is suitable for baseline core biopsy.
Patients must have histologically or cytologically confirmed breast carcinoma with a clinical diagnosis of IBC based on the presence of inflammatory changes in the involved breast, such as diffuse erythema and edema (peau d’orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis
For participants with breast cancer: HER2-negative disease as defined by local clinical guidelines
Prior reconstructive breast surgery, breast augmentation, mastopexy or reduction mammoplasty
Treated CIS of the breast or cervix
Breast feeding must be discontinued for the duration of therapy with vorinostat and the concomitantly used chemotherapy, if applicable
Patients must have measurable disease as defined by palpable lesion with both diameters >= 1 cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension >= 1 cm; screening mammogram of the contralateral breast must be performed within past 12 months per standard practice guidelines; clip placement is required for study entry; baseline measurements of the indicator lesions must be recorded on the Patient Registration form; to be valid for baseline, the measurements on clinical exam must have been made within the 14 days if the mass is palpable; if the mass is not palpable, a mammogram or magnetic resonance imaging (MRI) must be done within 14 days; if the mass is palpable, a diagnostic mammogram of the affected breast or MRI must be done within 2 months prior to study entry
Subjects with prior skin changes consistent with inflammatory breast carcinoma are eligible.
Breast carcinoma for medical reasons not being resected
Has a condition which may interfere with the hyperthermia portion of the trial such as: functioning cardiac pacemaker; metal plates, rods or prosthesis of the chest wall, breast reconstruction with implants, severe numbness and/or tingling of the chest wall or breast, skin grafts and/or flaps on the breast or chest wall.
Patient wishes to become pregnant\r\n* Note: patients who have undergone oocyte/embryo/ovarian tissue cryopreservation at breast cancer diagnosis and/or have a previous history of assisted reproductive technology (ART) are eligible
Breast cancer diagnosis, stage 1, 2, or 3 (solely for patients enrolled at Montefiore Medical Center, St. Barnabas, Jacobi Medical Center, and North Central Bronx)
Multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast)
Women must agree not to breast feed while on abemaciclib treatment and for at least three months following the last dose of study therapy
Are in breast cancer remission with no detectable disease present
Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy)
Women diagnosed with breast cancer stages 0-III within 18 months after completion of all planned surgery, radiation and or chemotherapy treatments
Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.
Any of the following breast cancer surgery complications; persistent seroma requiring aspiration, wound dehiscence, infection, prolonged drain output, lymphedema
Self-reported new onset since initiation of treatment cognitive dysfunction as determined by telephone screen using the brief (3 questions) assessment established by Ercoli et al. (endorsement on all three questions):\r\n* Do you think or feel that your memory or mental ability has gotten worse since you completed your breast cancer treatment? \r\n* Do you think that your mind isn't as sharp now as it was before your breast cancer treatments?\r\n* Do you feel like these problems have made it harder to function on your job or take care of things around the home?
PARTNER: Female/male intimate partner of a young breast cancer survivor who meets the above YBCS inclusion criteria
Obese breast cancer survivors and their overweight or obese partners
Diagnosed with breast, GYN, GI, GU, or thoracic cancer
Received first breast surgery of total or partial mastectomy within the previous 9 months
Subjects are status post (s/p) breast surgical intervention, to include mastectomy, partial mastectomy, lumpectomy, or reconstruction
Patients should be followed in Stefanie Spielman Comprehensive Breast Center (SSCBC) High Risk Breast Clinic
In early survivorship phase, defined as being post-surgery to ending of active treatment to 18 months post active treatment for stage 0-3 breast cancer (BCA)
Has been diagnosed with breast cancer, currently in remission or eradicated
Meet National Comprehensive Cancer Network (NCCN) criteria for consideration of genetic testing for hereditary breast cancer
Any woman with biopsy proven left breast DCIS or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist
Prospective study: individuals will have pathologically confirmed breast cancer (stages I-III)
Retrospective chart review: Individuals will have pathologically confirmed breast cancer or gynecological (GYN) malignancies including uterine, ovarian, or cervical cancers, stages I-III; treated in the previous two years (2013-2014)
Patients who have been surgically treated for breast cancer more than 3 months; healing usually occurs within 3 months of surgical treatment for cancer
Currently has breast implant (which limits the performance of many yoga poses)
Enrollment in a therapeutic intervention trial in the breast medicine service
Intact breast (not surgically absent)
The volume of the tumor bed (TB) clinical target volume (CTV) is less than 25% of the whole breast planning target volume (PTV) which is a criteria used for partial breast alone trials
Unable to fit into the immobilization breast cup with an adequate seal
Unable to fit into the breast immobilization device due to breast size or other anatomical reason
Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2)
Breast/s reconstructed with implant in the area of previous radiation
Subjects must be prescribed and scheduled for “conventional fractionated” RT without concurrent chemotherapy; bolus and intensity modulated radiation therapy (IMRT) are permitted; lymph node irradiation (i.e., internal mammary nodes, supraclavicular nodes, axillary nodes, etc) as part of their prescribed radiation therapy are permitted; conventional fractionated radiation therapy regimens eligible for study are described below:\r\n* Minimal (min) total dose: whole breast: 44 gray (Gy); breast boost: 10 Gy; tumor bed = whole breast +/- boost: 50.0 Gy; lymph nodes: 45 Gy\r\n* Maximal (max) total dose: whole breast: 50.4 Gy; breast boost: 20 Gy; tumor bed = whole breast +/- boost: 66.0 Gy; lymph nodes: 50.4 Gy\r\n* Min dose per fraction: whole breast: 1.8 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 1.8 Gy; lymph nodes: 1.8 Gy\r\n* Max dose per fraction: whole breast: 2.0 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 2.0 Gy; lymph nodes: 2.0 Gy\r\n* Min # of fractions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy\r\n* Max # of fractions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy\r\n* Min # of sessions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy\r\n* Max # of sessions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy
Subjects with breast reconstruction prior to RT
Presence of unhealed surgical wounds in chest or breast region and/or breast infection
Are not within 12 months of completing treatment for breast cancer (except hormonal therapies) at the time of recruitment;
Lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per breast surgeon or medical oncologist
Patients who have not undergone autologous tissue breast reconstruction and intend to undergo implant only breast reconstruction
Patients who have a history of breast tissue expander or implant placement
Patients must not have symptoms or signs of benign or malignant breast disease (e.g., bloody or clear nipple discharge, breast lump) based on physician physical exam or self breast exam; patients with breast pain are eligible as long as other criteria are met
To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above:\r\n* Patients are pre-menopausal; OR\r\n* Post-menopausal aged 45-69 with any of the following three risks factors:\r\n** Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or\r\n** Family history of breast cancer (first degree relative with breast cancer), or, participant positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, or\r\n** Currently on hormone therapy; OR\r\n* Post-menopausal ages 70-74 with either of the following two risk factors:\r\n** Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or\r\n** Currently on hormone therapy
Have not had both a breast MRI and mammogram in the previous 24 months
Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening
Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery
Participants who have received breast radiation within 1 year prior to screening breast MRI
Receives screening breast MRIs at an outside facility other than the consenting institution
CESM is an imaging exam that uses radiation and is not typically employed in women younger than age 30 due to potentially negative biologic effects on glandular breast tissue.
Participants who had a percutaneous breast biopsy (to include stereotactic, tomosynthesis, or ultrasound guided) that revealed ADH.
INCLUSION - PATIENT: Women presenting for breast cancer screening with either MRI or mammography: Group 1 will consist of women who present for screening breast MRI:\r\n* Asymptomatic for breast disease\r\n* Presenting for routine breast cancer screening with MRI
INCLUSION - PATIENT: Group 2 will consist of women who presented for a screening mammogram (2D or 3D tomosynthesis) AND who have had a biopsy recommended after diagnostic workup:\r\n* Initial presentation for routine breast cancer screening with mammogram (2D or 3D tomosynthesis) and/or ultrasound and\r\n* Biopsy recommended after subsequent diagnostic workup (breast imaging reporting and data system [BI-RADS] 4 or 5)
INCLUSION - RADIOLOGIST READER: Must have clinical experience in interpreting breast MRI
INCLUSION - RADIOLOGIST READER: Must have interpreted at least 10 breast MRI exams with RSI interpretation
EXCLUSION - PATIENT: Breast biopsy or surgical intervention planned before the test RSI-MRI in this study
Recommendation for breast biopsy has been made
CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)
For women who have not had any prior mammography (i.e. this is their first, baseline, mammogram), the breast tissue must be dense (heterogeneously dense or extremely dense) on the current mammogram
Recent prior breast surgery or breast biopsy or cyst aspiration within the prior 12 months
Women and men with symptomatic breast lump (either by palpation or imaging) OR
Patients with any clinical breast symptoms (palpable mass, nipple discharge, etc)
Have breast density assessed as >= 25% on a prior mammogram (Boyd 1995)
If undergoing regular screening, subject must have a mammogram performed at the University of Kansas Medical Center or other accredited facility within 1 year prior to their RPFNA procedure; mammograms must be read as not suspicious for breast cancer (American College of Radiology [ACR] class I-III) unless issue resolved with other procedures
Must be willing to keep the clinic informed of their breast health status for 10 years when requested
Women with a current mammographic or clinical breast exam mass which is suspicious for breast cancer (ACR class IV), and malignancy has not been ruled out
Patient’s breast density must be known; patients must have mammographically dense breasts, American College of Radiology (ACR) Breast Imaging (BI)- Reporting and Data System Atlas (RADS) lexicon categories c or d (heterogeneous or extreme fibroglandular tissue) on their most-recent prior screening
Patient must not have previously had molecular breast imaging (MBI, multiplexed ion beam imaging [MIBI])
Patient must agree to not undergo screening ultrasound (of breast) for the duration of the 1 year study period
BREAST CANCER SURVIVORS: Has no prior exposure to neurotoxic chemotherapy or radiation treatment;
BREAST CANCER SURVIVORS: Will be receiving either paclitaxel (Taxol or generic) either (a) weekly (~80-100mg/m^2) or (b) every other week (i.e., dose-dense) (~175 mg/m^2) Taxol for the treatment of breast cancer OR
BREAST CANCER SURVIVORS: Will be receiving an anthracycline and cyclophosphamide (AC) as a part of their initial treatment for breast cancer with plans to receive Taxol either weekly (~80-100mg/m^2) or every other week (i.e., dose-dense) (~175 mg/m^2);
Women considered at increased risk for developing breast carcinoma (those with a lifetime risk of > 15% due to family history, genetic predisposition, prior radiation therapy to the chest, prior biopsy showing a high risk lesion, or personal history of breast cancer) that are being screened with breast MRI
Mammograms must be read as not suspicious for breast cancer (American College of Rheumatology [ACR] class I-III); subjects with a class IV mammogram may be enrolled once they have been evaluated by a breast surgeon and there is no evidence of invasive malignancy
Less than 40 years if 5-year breast cancer Gail risk is >= 1.66%
Prior bilateral breast surgery (mastectomy, segmental mastectomy, or breast augmentation surgery including breast implants or breast reductions)
Most breast tissue expanders are not allowed; (if uncertain, inform the MRI tech to confirm eligibility status)
Women with current mammographic or clinical breast exam mass which is suspicious for breast cancer and malignancy has not been ruled out
BETA/USABILITY TESTING: Utilizing the breast cancer surveillance consortium risk calculator, women will have high 5-year (> 1.66%) risk for breast cancer and high breast density (heterogeneously or extremely dense)
Participants must have adequate accessible breast tissue as determined by the treating physician, consisting of one breast unaffected by invasive cancer, which has not been radiated; a history of benign core biopsy of this breast will be permitted
Participants need to have had a mammogram within 180 days of day 0 (normal/benign bi-rads 1 or 2) with no suspicion of a mass and no further routine breast imaging planned during the course of the study (4 weeks)
Prior bilateral breast surgery (mastectomy, segmental mastectomy, or breast augmentation surgery including breast implants or breast reductions) or combination of breast radiation and surgery involving both breasts
Patients with an implant in the sampled breast
Breast imaging: class I-III mammogram within 6 months of RPFNA; if class 0 or 4, must be resolved with additional procedures; if breast imaging pre and post study is performed at Kansas University Medical Center (KUMC), then volumetric assessment by Volpara software will be performed
Any newly identified breast abnormality requiring surgical excision
Mammogram performed or reviewed by an Ohio State University (OSU) radiologist at the Stefanie Spielman Comprehensive Breast Center or the James Cancer Hospital within the six months prior to study enrollment that are not suspicious for breast cancer (American College of Radiology [ACR] class I-III); subjects with a class IV mammogram may be entered following a negative biopsy
Must be willing to undergo fine needle aspiration of the contralateral breast for breast adipose tissue at 0, 3, 6, 9 and 12 months of the study and breast epithelial tissue samples at 0, 6 and 12 months of study
Subjects with insufficient breast adipose tissue and/or parenchymal breast tissue/breast density for adequate FNA sampling as determined by clinical examination and/or mammography
Must have at least one breast available for imaging and biopsy. A previously irradiated breast (i.e., for resected DCIS) is not evaluable for breast imaging or biopsy. a. Allow for submission of core needle breast material for future use.
Patients must have an unaffected, non-irradiated contralateral breast with a baseline breast density score of > 25% as measured by standard digital mammography (BIRADs score > 2) or magnetic resonance imaging (MRI) performed within 12 months of randomization to the study
The presence of gross skin invasion/ulceration by the breast cancer, or inflammatory changes with skin edema AND erythema; Note: Paget's disease is permitted
Women with skin diseases (psoriasis, eczema) on the breast
A 1st or 2nd degree relative with breast cancer diagnosed under the age of 60
If undergoing annual screening mammography, must have been performed within 9 months prior to baseline RPFNA and interpreted either as not suspicious for breast cancer or with any supplementary imaging performed and interpreted as not suspicious for breast cancer
Breast exam interpreted as normal (not suspicious for cancer)
Must have had a mammogram within the 12 months prior to study enrollment; mammograms must be read as not suspicious for breast cancer (American College of Radiology [ACR] class I-III); subjects with a class IV mammogram may be entered once they have had a negative biopsy
Subjects must have had a normal mammogram or breast MRI within 9 months prior to registration; NOTE: subjects must also have a normal breast exam on the day of the pre-intervention studies
Subject has multi-centric breast cancer
Upon clinical exam and pre-operative imaging by mammogram +/- MRI, two or three foci of biopsy proven breast cancer separated by >= 2 cm of normal breast tissue; foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS); no more than 2 quadrants with biopsy proven breast cancer; Note: the shortest distance between lesions must be reported on mammogram +/- MRI and eligibility criteria must be met on both, if both are obtained; Note: patient is eligible for study if lesion is not visualized on all imaging modalities (i.e., any of the lesion (s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI); ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram +/- MRI only; fine needle aspirate of the second or third lesion to document malignancy is allowed if the first focus is shown to be invasive by core needle biopsy; patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion
Bilateral mammogram =< 90 days prior to date of surgery; Note: for patients undergoing more than 1 breast operation, this is the date of the first breast surgery for breast cancer treatment
Planned partial breast radiation
Mammogram negative for breast cancer within the 12 months preceding the time of registration for women >= 50 years of age
Mammogram within no more than 6 months prior to the date of informed consent (normal/benign Breast Imaging-Reporting and Data System [BI-RADS] 1 or 2) and no further routine breast imaging planned during the course of the study (12 weeks DHA/placebo)
Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies
Bilateral breast malignancy or suspicious mass in opposite breast
The imaging abnormality must have been categorized as Breast Imaging-Reporting and Data System (BIRADS) level 1-4 lesion
Operable breast cancer treated with NAC undergoing either breast conservation or total mastectomy who have had a post-NAC clinical bilateral breast MRI demonstrating a complete imaging response, which is defined as no residual tumor enhancement
Any woman who has completed or is nearing completion of neoadjuvant therapy for breast cancer and is scheduled for a post-NAT breast MRI and mammogram
Diagnosed with a Breast Imaging Reporting and Data System (BI-RADS) score of 4 or higher breast abnormality greater than 1cm in size
Known or suspected (Breast Imaging Reporting and Data System [BIRADS] 5 on imaging) primary breast cancer
At least one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast magnetic resonance imaging [MRI]); only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study; patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included
Involvement in another therapeutic trial for breast cancer at Dana Farber or elsewhere
No prior history of breast reconstruction, reduction, or augmentation
Known or suspected breast cancer with at least one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast magnetic resonance imaging [MRI]); only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study; patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included
HEALTHY VOLUNTEER: A history of surgical breast augmentation, reduction, or biopsy
PATIENT: Patients who have had prior breast reduction
Has biopsy-proven invasive breast cancer (Breast Imaging Reporting and Data System [BI-RADS] 6) and scheduled for neoadjuvant chemotherapy (NAC)
Scheduled for breast core needle or surgical biopsy of at least one breast lesion based on suspicious breast lesion (Breast Imaging Reporting and Data System [BIRADS] score of 4 or 5) from pre-study standard of care (SOC) imaging studies
Participants must have clinical characteristics consistent with IBC, characterized by a rapid onset of clinical findings exemplified as diffuse edema and erythema of the breast, often without a palpable mass
Scheduled for mammogram, breast ultrasound and/or breast MRI
Breast size per visual inspection to fit within the ultrasound tomography (UST) ring array
No open breast or chest wounds
Diagnostic findings from prior mammography highly suggestive of breast malignancy (Breast Imaging-Reporting and Data System [BI-RADS] [R] category 4) or known biopsy-proven malignancy (BI-RADS [R] category 5)
Symptomatic of any breast abnormality
Recent breast biopsy
Biopsy confirmed malignancy associated calcifications in at least one breast
Subjects for whom an MRI is technically not feasible (e.g. breast volume, obesity)
Unresected, untreated breast cancer that meets one of the following clinical stages:\r\n* T2, T3, or T4a-c lesion, any N, M0\r\n* Note: Patients with inflammatory breast cancer (T4d) are not eligible; bilateral cancers are permitted with approval of the Protocol Chair; participants with clinically evaluable disease will be followed for response by clinical examination; measurable disease is not required for participation
Women with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5
Required studies include diagnostic mammogram of the affected breast within 3 months prior to registration, and a two-view (full view craniocaudal [CC] and a full view mediolateral oblique [MLO]) mammogram of both breasts within 6 months of registration (if the patient has only one breast, a unilateral exam of the intact breast is required)
Multicentric breast cancer, defined as two or more tumors in different quadrants of the breast
Be a female diagnosed by x-ray mammography (performed within 90 days prior to the study procedure) as having a solid breast mass or abnormal area without a mass
Patients whose breast lesion is unequivocally a cyst by unenhanced US
Patients with DCIS or invasive breast cancer who are scheduled for a lumpectomy or mastectomy and are receiving surgical care from the Breast Surgery Department at Columbia Medical Center
Breast size and epithelial integrity adequate to allow NIR imaging exams
Patients will be identified as possible participants in the Radiology Imaging suites and Breast Surgery Clinics
Subject has had preoperative radiation therapy to the affected breast or axilla.
The primary breast tumor must be detectable by mammogram or breast ultrasound at the time of diagnosis
The primary tumor is not visualized by mammogram or breast ultrasound at the time of diagnosis
Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast
Have a prosthesis/implant in the operative breast
The use of statins including atorvastatin are prohibited and patients should be moved on to non-breast cancer resistance protein (BCRP) alternatives
Participants must have a mammographic breast composition category (density) of c or d
PHASE I: Women with estrogen receptor (ER)+, HER2-, lymph node (LN)-, breast cancers < 3 cm who were diagnosed with a first primary breast cancer > 6 months ago and < 2 years ago
Surgeon: Performs breast reconstruction procedures after mastectomy
Women who (1) have a personal history of a single stage 0-2 breast cancer, (2) were recently diagnosed within the past 6 months, and (3) are treated at a participating breast oncology clinic.
Patient deemed clinically appropriate for adjuvant breast or chest wall radiation following surgery
Attend the Cancer Therapy and Research Center (CTRC) breast clinic
positive clinical breast examination
Requiring chronic treatment with breast cancer resistance protein (BCRP) inhibitors.
Subjects with prior breast surgeries, mastectomies, breast reconstructions or implants. (Note: subjects who have had prior breast biopsies are not excluded)
Has completed treatment for Stage I-III breast cancer, if indicated, and ?6 months elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence.
Adult women with breast cancer who have undergone surgery for their primary breast tumor (either lumpectomy or mastectomy +/- reconstruction) and are confirmed to have involved lymph nodes on surgical pathology
Suitable for breast conserving surgery and radiotherapy
All women who undergo breast conserving therapy must receive concomitant radiotherapy; radiation after mastectomy is to be administered according to pre-specified institutional guidelines; radiation must be completed at least 21 days prior to registration
Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging; a negative margin is defined as no evidence of tumor or ductal carcinoma in situ (DCIS) at the line of resection; additional operative procedures may be performed to obtain clear margins\r\n* Patients who had breast-conserving surgery must have completed whole breast radiation; use of regional nodal basin radiation will be at the discretion of the investigator according to institutional guidelines\r\n* Patients with >= 4 positive lymph nodes must have completed breast/chest wall and nodal basin radiation therapy according to standard of care guidelines before randomization; omission of radiation therapy is not allowed in this high-risk population of patients\r\n* Patients must be registered at least 21 days after completion of radiation therapy and must have recovered (=< grade 1) from any of the effects of radiation
Cancer patients with stage 0-III breast cancer (BrCA) treated with breast conserving surgery or mastectomy and clear margins will be recruited to the study
Patient has elected breast-conserving surgery (BCS) as surgical treatment for early-stage breast cancer
No contraindication to breast conserving surgery, sentinel lymph node biopsy, or radiation therapy
Operable DCIS, suitable for breast conserving surgery
Appropriate candidate for breast-conserving surgery based on multi-disciplinary assessment
Subjects are not a candidate for breast conserving surgery
Patient desires breast conserving therapy
Patients must have undergone breast-conserving surgery
The tumor has been excised with a breast-conserving resection and there is no tumor seen at any of the margins of the resection
The primary tumor must be excised via breast conserving surgery (“lumpectomy”) with negative margins (no ink on tumor) in the final specimen
Participant agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy
Whole breast radiotherapy is required for patients who underwent breast conserving therapy, including lumpectomy or partial mastectomy. Patients receiving adjuvant radiation therapy must have completed radiotherapy at least 14 days prior to registration for protocol therapy.
Planning to undergo breast-conserving surgery
Preference for mastectomy instead of breast-conserving surgery
Patients must not have had prior ipsilateral breast-conserving surgery or total mastectomy and be eligible for neoadjuvant treatment
Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
Whole breast radiotherapy is required for participants who underwent breast-conserving therapy, including lumpectomy or partial mastectomy. Participants must have completed radiotherapy at least 14 days prior (but no more than 84 days prior) to study registration.
Definitive surgical treatment with breast-conserving surgery or mastectomy and axillary lymph node evaluation.
Treatment with breast conserving surgery
Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy
Systemic chemotherapy prior to final breast conserving surgery
Patients must have been treated by breast conserving surgery (BCS) or mastectomy
Will be two weeks post-breast conserving surgery or three weeks post-breast conserving surgery with sentinel lymph node biopsy or four weeks post-mastectomy at the start of participation
Women who have undergone a total mastectomy or breast-conserving surgery for primary breast cancer +/- chemotherapy, +/- radiotherapy
The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy)
Patients eligible for the study will be newly-diagnosed female breast cancer patients with stage I-ll invasive breast cancer who are eligible for and considering either mastectomy or breast-conserving surgery (BCS) with radiation, and who may be eligible for adjuvant systemic treatment
Breast conserving surgery and indications for whole breast radiotherapy
Patients must be undergoing breast conserving therapy
No patients scheduled to receive partial breast irradiation following breast conserving surgery
Participants must be candidates for definitive local therapy with breast conserving therapy or deemed as potential candidates following NAT (this takes into account tumor to breast size ratio appropriate for breast cancer therapy [BCT], and the ability to undergo standard radiation therapy post-operatively)
Participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for breast-conserving surgery [BCS], and the ability to undergo standard radiation therapy post-operatively)
Eligible for breast conserving surgery, lumpectomy and radiation
Patient desire to undergo breast conserving surgery
The subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery or has received the Gliadel® wafer < 30 days from W1D1 (surgery)
Patients must begin treatment as outlined in the protocol within 36 days of definitive surgery (day of surgery is day 0; definitive surgery includes second surgeries to resect residual tumor)
No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration
Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery
Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1422\r\n* Patients must be enrolled within 36 days of definitive diagnostic surgery (day 0)\r\n** Note: patients must begin treatment within 36 days of definitive surgery
Patients with residual macroscopic disease after surgery
Patient must have received either P/D or EPP and must have recovered from all effects of surgery with adequate wound healing; patients who received radiation therapy (RT) must be registered to step 3 within 28 days after discontinuing RT; patients who did not receive RT must be registered to step 3 within 56 days after surgery
Patients currently being treated for severe infections or who are recovering from major surgery or other intercurrent illnesses are ineligible until recovery is deemed complete by the investigator
Subject has received surgery within the last four weeks.
Major surgery other than diagnostic surgery, within 4 weeks prior to the first dose of test drug, minor surgery including diagnostic surgery within 2 weeks (14 days) excluding central IV port placements and needle aspirate/core biopsies. Radio frequency ablation or transcatheter arterial chemoembolization within 6 weeks prior to the first dose of test drug.
Patients who cannot undergo surgery
All patients who have surgery performed must have a cranial MRI pre-operative and post-operative (should be done within 72 hours of surgery or within 21 days following surgery)
Surgery to the lesion in question is allowed if size criteria outlined above are met
Patient has had surgery within seven days prior to the date of informed consent.
Participants who underwent major surgery (including craniotomy) or significant traumatic injury within 28 days prior to initiating therapy; baseline MRIs for participants who underwent salvage surgery must be obtained within 14 days of registration (similar to other patients who do not have surgery) and there must be measurable disease
Successful Avatar engraftment from initial surgery or surgery/biopsy of recurrent cancer with successful expansion and treatment outcome of Avatar therapy
Patients must be able (physically, mentally and socially) to complete a series of RT, followed by an observation period of 4-6 weeks and undergo surgery.
Patients must have surgery planned to remove the desmoid tumor and either:
the desmoid tumor has already recurred after a prior surgery or
Planned procedure or surgery during the study
Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 7 days prior to surgery
Concurrent therapy with drugs active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir); participants must be off treatment with these agents for at least 7 days prior to surgery
Completed pre-operative chemo radiotherapy followed by surgery
Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery
Surgical patients must have tumor that needs to be removed/debulked and is accessible for the neurosurgeon; need for surgery must be such that the patient can take drug for at least 10 days to maximum 14 days before surgery
Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery
Presence of any of the following risk factors after surgery:\r\n* Any positive surgical margin.\r\n* Adenopathy below the clavicles
Not eligible for surgery
At least 4 weeks post-surgery prior to first dosing of study agent
Patients who have been treated with pemetrexed if the last dose of pemetrexed is < 8 weeks to the date of surgery
Timing of radiation must be according to the IRS protocol upon which the patient is treated within either 35 days of last chemotherapy or surgery; the clinical characteristics dictate the need for or/and timing of surgery and radiotherapy in relation to the chemotherapy
Platelets > 80,000 compatible for surgery
Elective indication for nephron sparing surgery
Recovery of reversible effects of prior surgery (i.e., incisional pain, wound drainage) to grade >= 1, and at least 4 weeks from prior surgery to treatment start
Scheduled to undergo chest surgery using either minimally invasive (VATS or robotic-assisted surgery) or open techniques (posterolateral, lateral, or anterior thoracotomy or requiring insertion of an inter-rib spreader/retractor) for a primary thoracic non-infectious indication under general anesthesia.
Surgery unable to be performed between 1 – 3 days after radiosurgery
Substantial recovery from surgery resection
Deemed ineligible for surgery by the enrolling physician
Patients must have consented to surgery with an MSK gynecology (Gyn) surgeon
INCLUSION CRITERIA:\n\n        SONICS STUDY COMPLETERS:\n\n        Completed the final SONICS visit (M12) and have demonstrated maintenance of clinical\n        response on a stable Therapeutic Dose of levoketoconazole for at least 12 weeks prior to\n        study entry.\n\n        ALL OTHERS:\n\n          -  Confirmed newly diagnosed, persistent or recurrent endogenous Cushing's syndrome of\n             any etiology, except secondary to malignancy (including pituitary or adrenal\n             carcinoma).\n\n          -  Elevated mean 24-hour UFC levels at least 1.5X upper limit of the normative range of\n             the study's central laboratory assay and from a minimum of three measurements from\n             adequately collected urine.\n\n          -  Presence of abnormal values from at least one of these two diagnostic tests:\n\n               -  Abnormal Dexamethasone Suppression Test (DST) OR\n\n               -  Elevated late night salivary cortisol concentrations (at least two measurements)\n                  each greater than the upper limit of the study's central laboratory normative\n                  range\n\n          -  Non-candidates for CS-specific surgery, refuse surgery or surgery will be delayed\n             until after study completion and agree to complete this study prior to surgery.\n\n          -  If post-surgical for CS-specific surgery, then no significant post-operative sequelae\n             remain and the risk of such sequelae is considered negligible.\n\n        EXCLUSION CRITERIA:\n\n        Subjects will be excluded from the study if ANY of the following criteria are met (NOTE:\n        exclusion criteria apply to and must be assessed in both cohorts):\n\n          -  Enrolled in SONICS but have not completed SONICS through Visit M12.\n\n          -  Pseudo-Cushing's syndrome based on assessment of the Investigator.\n\n          -  Cyclic Cushing's syndrome with multi-week periods of apparent spontaneous CS\n             remission.\n\n          -  Non-endogenous source of hypercortisolism, including pharmacological corticosteroids\n             or ACTH.\n\n          -  Radiotherapy of any modality directed against the source of hypercortisolism within\n             the last 5 years.\n\n          -  Treatment with mitotane within 6 months of enrollment.\n\n          -  History of malignancy, including adrenal or pituitary carcinomas (other than low-risk,\n             well-differentiated carcinomas of thyroid, breast or prostate that are very unlikely\n             to require further treatment in the opinion of the treating physician, or squamous\n             cell or basal cell carcinoma of the skin).\n\n          -  Clinical or radiological signs of compression of the optic chiasm.
Prior biliary bypass surgery
Pituitary surgery within six months
Laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.
Patients must have measurable lesion(s) and one or more of the following criteria:\r\n* Failure of surgery to control disease (i.e. positive margins or recurrence of HSIL after surgery)\r\n* Multifocal or extensive disease for which surgery would result in major deformity that is not be acceptable to the patient\r\n* Disease for which surgery would have a risk of functional impairment that is not be acceptable to the patient (i.e. involve partial or complete excision of the clitoris, anus, vagina, or urethra)
Medically inoperable or patient refusal to surgery as defined by any single of the following criteria\r\n* Determined unfit for surgery by thoracic surgeon or radiation oncologist as documented in the medical record\r\n* Pulmonary function tests (PFTs) showing forced expiratory volume in 1 second (FEV1) =< 1.2 L or diffusion capacity of the lung (DLC) < 60%\r\n* Poor exercise tolerance or failed pre-operative cardiac work-up\r\n* Patient refusal to undergo definitive surgery as documented in clinical note by a surgeon, pulmonologist, medical oncologist, or radiation oncologist
Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy); or
Cutaneous HNSCC must not be amenable to local treatment modalities, including surgery and/or radiation
Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor placement
Patients who underwent surgery for a progressive plexiform neurofibroma will be eligible to enter the study after the surgery, provided the plexiform neurofibroma was incompletely resected and is measurable
Treatment must be initiated >= 14 days and < 6 weeks from surgery
Medical indication or subject desire to undergo BC surgery prior to completing at least 14 days of treatment with ODM-201.
Planned to get local surgery
Plan to proceed to surgery following peri-operative chemotherapy based on standard staging studies per local practice
Pathologically-confirmed invasive breast cancer; if patients undergo upfront surgery, the pathologic stage must be T0-T3, N0-N2a or N3a; if patients receive neoadjuvant chemotherapy prior to surgery, the clinical stage must be T0-T3, N0-N2a or N3a
Be willing to allow use of archival tissue from second-look surgery and primary surgery or biopsy for use in this study
Stage IV disease, if the metastatic sites are not amendable for local therapy (i.e. radiation and/or surgery), and are not candidates for breast surgery will not be eligible
Participant has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing; participants with bowel resections at surgery should begin protocol at least 42 days after surgery
Any stage, considered candidates for surgery and scheduled for surgery either by robotic or by standard surgical technique
The patient’s refusal to proceed with curative breast surgery has to be documented by the surgeon’s and medical oncologist’s note
Adequate recovery from all recent surgery is required. At least 21-days must have elapsed from the time of any major surgery, including craniotomy/tumor resection. Patients must have recovered from all surgery-related toxicities to Grade 1 or less.
If they have not previously had a video assisted thoracoscopic surgery, and they have a free pleural space to allow for a video assisted thoracoscopy surgery (VATS) procedure, then they must be willing to undergo a VATS for adequate histologic staging
Inability to safely delay surgery by 8 weeks as per surgeon’s discretion
No prior definitive surgery for HNSCC
Prior breast surgery which interrupts communication of the ductal systems with the nipple
Evidence of residual disease after surgery and SoC adjuvant therapies
Patients who have had secondary debulking surgery
Patients must begin treatment as outlined in the protocol within 42 days of definitive surgery (day of surgery is day 0; definitive surgery includes last surgery to resect residual tumor)
Patients must begin treatment within 42 days of definitive surgery (day of surgery is day 0; definitive surgery includes repeat surgeries to resect residual tumor)
Patients will be consented prior to the surgical evaluation/cytoreductive surgery; patients must have less than or equal to 0.5 cm residual disease at the completion of the secondary surgery to be eligible for the study
Major surgery (includes any surgery that carries significant risk of blood loss, extended periods of general anesthesia, or requires at least an overnight hospital admission) within 28 days before starting treatment or inadequately healed incision/scar from prior surgery
Prior surgery for this cancer
Status post above elective surgery =< 30 days after first registration\r\n* Elective surgery is defined as:\r\n** Patient was brought from their home (or normal living environment) to FCCC on the day prior to surgery or the day of the index surgery AND\r\n** Surgery was not scheduled/performed as urgent or emergent
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Not able to receive the vaccination within 10 weeks following the surgery secondary to a delayed recovery from the surgery
Women must not become pregnant prior to surgery or during the first 3 months after surgery; women who can become pregnant will be asked to practice an effective form of birth control for up to 3 months after surgery
Therapy must begin =< 5 weeks after surgery or biopsy
Before administering liposomal doxorubicin, patients must wait 4-6 weeks after surgery
Patients found to have non-gynecologic, uterine, or breast primary at surgery
Patient is medically unfit for surgery or is deemed surgically unresectable by head and neck (H&N) surgeon within 60 days prior to enrollment, or patient refusal of surgery
Becomes pregnant before surgery or at any time while on study
Subjects having undergone recent resection or biopsy of an intracranial tumor will be eligible as long as all of the following conditions apply: \r\n* First dose of cabozantinib occurs at least 28 days after surgery, and the subject has recovered from the effects of surgery
Macroscopic residual disease after surgery
Patients may not have had any prior tumor treatment except for surgery, and must have adequately recovered from surgery
The patient is able/eligible to undergo treatment with transoral surgery (transoral laser microsurgery [TOLM] or transoral robotic surgery [TORS]) with or without neck dissection and with or without adjuvant radiation therapy or chemoradiation
Patients who have undergone a major surgery, including surgery for a new artificial implant and/or device, within 6 weeks prior to the initiation of ADXS11-001 treatment; NOTE: All toxicities and/or complications must have recovered to baseline or grade\r\n1 prior to the initiation of ADXS11-001 study therapy; sponsor must be consulted prior to enrolling subjects on the study who recently had a major surgery or have new artificial implant, and/or devices
It is strongly encouraged that all patients have metallic clips placed in the tumor prior to neoadjuvant therapy in order to facilitate evaluation for microscopic disease at the time of surgery; placement of clips is particularly encouraged for patients being considered for breast conserving surgery
Surgery (including open biopsy), significant traumatic injury within 28 days prior to randomization, minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion is allowed
Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
Patients who have had non-biopsy surgery in the last 10 days
If markers were not placed at the time of surgery and are needed, patient must have markers placed within 6 weeks after surgery.
Patients must begin partial brain radiotherapy and temozolomide chemotherapy no sooner than 2 weeks and no later than 6 weeks from the surgery in which pathology was confirmed; if a patient elects to have a second surgery to obtain further resection, they will remain eligible for treatment as long as no treatment has been initiated prior to this surgery; in this case, initiation of treatment must begin within 2 to 6 weeks from the last surgery; tissue collection is preferred but not mandatory; patients may have radiotherapy administered at outside facilities; radiotherapy must be given within 2 days of lapatinib initiation and by external beam to a partial brain field in daily fractions of 2.0 Gy, to a planned total dose to the tumor of 60.0 Gy; stereotactic radiosurgery and brachytherapy will not be allowed
Subjects with recurrent or progressive glioma who have failed standard therapy with surgery and/or radiation for whom local therapy has been requested by the neuro-oncologist. This treatment will be offered as an option for those patients where neither surgery or repeat radiotherapy is advised by the multidisciplinary team. OR Patients with metastatic brain cancer that has progressed despite prior radiotherapy and local therapy is requested by the oncologist. This treatment will be offered as an option for those patients where surgery is not indicated and discussed with the potential options for repeat radiotherapy or salvage radiosurgery by the multidisciplinary team.
ELIGIBILITY CRITERIA FOR REGISTRATION: subjects undergoing primary debulking surgery must have stage III or IV disease and have undergone surgery to include, at a minimum, removal of the uterus, ovaries and fallopian tubes; these patients may be optimally debulked (less than 1 cm residual disease) but must have grossly visible macroscopic residual disease OR be suboptimally debulked
Patients with resectable disease will be eligible for participation if, and only if, they have comorbidities precluding surgery or refuse to undergo an operation following a multi-disciplinary discussion involving surgical oncology, medical oncology, and radiation oncology; this discussion will actively involve the patient and reinforce that surgery is the current standard of care for such patients
All patients who have surgery performed must have a cranial MRI pre-operative and post-operative (should be done within 72 hours of surgery or within 21 days following surgery)
Surgery: Subjects who have received hepatic surgery, ablation or chemoembolization within 4 weeks of PV-10 administration.
The patient must be enrolled and have treatment planning between 14-63 days from date of last surgery or last cycle of chemotherapy, and radiation must start within 21-63 days of date of last surgery or last cycle of chemotherapy
The attending surgeon considers the mass to be amendable to robotic assisted surgery
Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
Participant is able to undergo surgery (planned lobectomy or wedge resection)\r\n* Specifically, the participant has been or will have been cleared for surgery at the time of enrollment; the surgeon can accept the baseline tests done within 45 days prior to SBRT to clear the patient for surgery
Patients must be deemed to be in adequate health to undergo major surgery (pancreaticoduodenectomy)
Minor surgery within 7 days of first dose of STA-9090
History of gastric or small bowel surgery.
Prior areolar or breast surgery which interrupts communication of the ductal systems with the nipple
Plan to begin partial brain radiotherapy within 24-72 hours after beginning AQ4N, and within 35 days (5 weeks) of the surgery, or if surgery cannot be performed, the biopsy that confirms GBM diagnosis. Radiation therapy must be given by external beam to a partial brian field in daily fractions of 2.0 Gy, to a planned total dose to the tumor of 60.0 Gy over 6 weeks.
Patients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive diagnostic surgery (Day 0)
Who have had non-biopsy surgery in the last 10 days
Standard preoperative evaluation is performed and deemed satisfactory to proceed to surgery as per their treating urologist
Patients must have undergone surgery and must not have had any further treatment following surgery. Patients must have undergone surgery of their glioblastoma (GBM), and must not have had any further treatment following surgery. A minimal interval of 7 days between the day of surgery and the day of inclusion should be respected; a maximal interval of 31 days between the day of surgery and the day of inclusion should be respected; the patient should have fully clinically recovered from the surgery. (For stage 2: radiation with concurrent and adjuvant EDO-S101 only)
The subject must have received maximal debulking surgery and undergo radiotherapy concomitant with temozolomide (45-70 gray [Gy])
Ibrutinib should be held at least 3 to 7 days pre- and post-surgery, depending upon the type of surgery and risk of bleeding
Recent resection of recurrent or progressive tumor allowed as long as at least 4 weeks have elapsed from date of surgery and the subject has recovered from surgery
Participants must have had prior debulking surgery.
Recent (i.e., ? 6 weeks) history of abdominal surgery or peritonitis
Children less than 8 months of age at the time of definitive surgery with or without measurable radiographic residual tumor with M0 stage medulloblastoma will be eligible for study entry
Patients who require WBRT or surgery at the time of enrollment
Patients who are not currently candidates for radical cystectomy (e.g. patient refuses surgery, comorbidities preclude major surgery, etc.)
Not likely curable with surgery alone
Patients must be entered between 1 and 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction
Participants who undergo primary cytoreductive surgery must be entered between 1 and 12 weeks after surgery. Participants undergoing interval surgery must have a tumor sample confirming the histological diagnosis prior to enrollment.
Patients may be optimally or suboptimally debulked after surgery
Not curable by surgery.
Subject is scheduled for another surgery during the first 6 months following surgery (not including stoma closure ,placement of port for chemotherapy or ureter stent insertion).
Previous TransOral Robotic Surgery (TORS) to the oropharynx
If a second surgery is needed for completion of resection, this should be within 30 days from the first surgery
Patients must not have had a previous surgical resection; however, patients may have undergone exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgery for the purpose of determining the diagnosis, stage or potential resectability of newly diagnosed lung tumor; at least 28 days must have elapsed since thoracic surgery (excluding mediastinoscopy or other minor surgeries) and patients should have recovered from all associated toxicities at the time of registration; patients must not be planning to undergo a minor surgical procedure while on this study
Treatment directed against the resected melanoma that is administrated after the surgery
Breast surgery planned
Patients with a history of prior pituitary surgery must be at least 30 days post-surgery to be eligible for inclusion in this study.
Have significant loss of gastrointestinal organs, except for appendix, due to surgery
Adequate recovery from all recent surgery is required; at least 1 week must have elapsed from the time of a minor surgery; at least 21 days must have elapsed from the time of a major surgery. Patients must have recovered from all surgery-related toxicities to Grade 1 or less.
Resolving hemorrhagic changes related to surgery.
Pregnant at time of surgery
Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery;
Subject receiving antiplatelet medications within 5 days prior to surgery;
Subject undergoing abdominal or orthopedic lower extremity surgery receiving aspirin within 7 days prior to surgery;
If patients underwent surgery, and chemotherapy is indicated after surgery either as adjuvant or to treat residual disease, study treatment should be initiated within 8 weeks of surgery
Patients must not have disease that is currently amenable to surgery; prior surgery is allowed no less than 6 weeks prior to study entry
Patient desire to undergo breast surgery
Post surgery:\r\n* Must be a minimum of 14 days from surgery before treatment may be initiated\r\n* Craniotomy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of registration\r\n* Post tumor resection, all patients must have a post-operative magnetic resonance imaging (MRI) done no more than 72 hours after surgery; if post-op MRI was not completed within this time frame, a MRI must be completed > 4 weeks (+/- 7 days) after surgery, but before initiation of radiation treatment in order for an accurate assessment to be done post-radiation
Prior therapy or surgery (3 to 10 weeks depending type)
At least 4 weeks must have lapsed since major surgery (e.g., laparotomy, laparoscopy, thoracotomy, video assisted thoracoscopy) prior to study treatment initiation
At least 3 months have elapsed between any prior brain radiotherapy and initiation of study therapy (unless the subject recently underwent surgery for proven or suspected disease recurrence, the histology of the most recent surgery demonstrated recurrent/progressive/persistent malignant glioma, Gliadel wafers were not placed during the most recent surgery, neither convection enhanced delivery nor catheters for infusion of chemotherapy were use during the most recent surgery, and radioactive seeds were not placed during the most recent surgery)
No history of bariatric surgery
Subjects who underwent surgery for a progressive plexiform neurofibroma will be eligible to enter the study after the surgery, provided the plexiform neurofibroma was incompletely resected and is evaluable by volumetric analysis
No contraindications to limb-sparing surgery; patient should be evaluated by a surgeon who specializes in sarcoma resections prior to study enrollment to ensure patient (pt) is a candidate for limb-sparing surgery
Surgery or local prostatic intervention within 4 weeks of the first dose; in addition, any clinically relevant issues from the surgery must have resolved prior to cycle 1, day 1
Eligible to undergo excisional surgery such as pleurectomy/decortication (P/DC) or any other mesothelioma surgery.
No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization
Patients with brain metastasis are eligible for participation ONLY if they have been treated with definitive surgery or radiation (surgery +/- radiotherapy, radiosurgery, or gamma knife) and meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 12 week interval
For those participants who do not require radiation, registration must be within 84 days of surgery.
Margin negative surgery
Surgery or local prostatic intervention within 30 days of the first dose; in addition, any clinically relevant issues from the surgery must have resolved prior to enrollment
Presence of any of the following risk factors after surgery:\r\n* Any positive surgical margin\r\n* Adenopathy below the clavicles
Patient must be registered/randomized to Step 2 within a maximum of 7 weeks following surgery
Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery.
Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible).
Any surgery (including diagnostic laparoscopy and/or biliary +/- duodenal palliative bypass for inoperable PC) within the 2 weeks prior to day 1 of study protocol
Therapy must begin =< 5 weeks after surgery
Patients may have received Gliadel during surgery
Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).
Cohort 1: Patients must have undergone surgery or biopsy alone (no postoperative radiation or chemotherapy) and have a baseline MRI scan (within 4 weeks of the first vaccine) that shows stable disease or regression (no progression from the initial surgery/biopsy)
Surgery within 2 weeks prior to dosing
Presence of systemic illness precluding definitive surgery or increasing the risk to patients due to potential immunosuppression.
History of gastrointestinal perforation within 12 months of randomization, except for gastrointestinal (GI) perforation related to a primary colorectal tumor that has subsequently been fully resected; subjects would be eligible if >= 4 weeks have elapsed from the time of surgery to start date of chemotherapy on protocol and >= 6 weeks have elapsed from time of surgery to first dose of bevacizumab; the subject must have recovered from the effects of the surgery (e.g. wound is healed, no active infection, no drains, etc.)
Subjects with chordomas must be considered to have high risk disease as defined by:\r\n* Local recurrence after surgery alone\r\n* Prior intralesional resections\r\n* Unplanned incomplete resections\r\n* Tumors are unresectable or at best marginally resectable based on locally advanced stage, and\r\n* Patients who decline surgery due to excessive morbidity and would otherwise receive non-operative treatment with radiation and/or medical management if not treated on clinical trial
Patients with a history of atherosclerotic coronary artery disease that required bypass surgery may only be enrolled provided that bypass surgery occurred at least one year prior to enrollment and after consultation with a cardiologist to determine stability of disease
Participants need not have measurable disease; lesion may be primary or recurrent after prior surgery; patient tumor status:\r\n* Status post biopsy only and no further surgery planned\r\n* Status post resection with gross residual disease\r\n* Status post grossly complete resection but with margins positive or close (=< 10 mm)\r\n* Status post biopsy and patient to have additional surgery and radiation
Patient has undergone a major surgery, including surgery for a new artificial implant and/or device, within 6 weeks prior to the initiation of ADXS11-001 treatment; NOTE: all toxicities and/or complications must have recovered to baseline or grade 1 prior to the initiation of ADXS11-001 study therapy; sponsor must be consulted prior to enrolling patients on the study who recently had a major surgery or have new artificial implant, and/or devices
Subject has had prior cytoreductive surgery yielding tumor for lysate preparation
Subject has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing; subjects with bowel resections at surgery who enroll in cohort 3 will begin protocol at least 42 days after surgery if debulking surgery had comprised of bowel resection or other bowel surgery
Following surgery, the patient must have received external beam radiotherapy (58-66 Gy in 2 Gy fractions, 5 days per week) with concomitant cisplatin starting within 8 weeks of surgery. A brief delay in the initiation of radiotherapy following 8 weeks post-surgery due to administrative reasons (e.g., start of RT on Mondays) may be permitted by the Medical Monitor. The cumulative dose of cisplatin the subject received must be > 150 mg/m2. Protocol therapy must be initiated within a period of 4-8 weeks (28-56 days) following the end of RT.
History of surgery within last 28 days
Patients must be entered no later than 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction.
Patients with or with anticipation of invasive procedures as defined below: Major surgical procedure within 28 days of initiating bevacizumab or major procedures anticipated during the course of the study. This includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression, such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery.
Patients who have metastatic disease, if the metastatic sites are amendable for local therapy (i.e. radiation and/or surgery), and are candidates for breast surgery will be eligible
Prior interstitial radiotherapy, stereotactic or gamma knife surgery or implanted BCNU-wafers
Patients must begin treatment as outlined in the protocol within 31 days of definitive surgery
Estimated blood loss > 2 liters during surgery
Patient must have the presence of residual resectable disease for which surgery is clinically indicated, and will be performed at All Children’s Hospital
Subjects with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, biliary, gastrointestinal bypass) are eligible, if the subject has fully recovered from surgery and >= 14 days has passed since the operation; patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence
Requires upper and lower limb surgery that will affect functional outcomes,
For subjects receiving adjuvant therapy only, time between definitive surgery and randomization must be ? 12 weeks. Definitive surgery may include secondary interventions (e.g. to clear inadequate surgical margins)
Interval of at least 3 weeks after biopsy or open surgery and able to begin study treatment.
Recent resection of recurrent or progressive tumor allowed as long as at least 4 weeks have elapsed from date of surgery & subject has recovered from surgery
Indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation, transplantation)
Any prior surgery at the proposed treatment site OR any prior surgery involving the cryoablation-treated tumor
SURGERY:
Presence of residual disease on final pathology following surgery will be required for immunotherapy; patients with no residual disease at the time of surgery will be removed
Any BCC that may require Mohs surgery for definitive control
Subjects who have participated in another investigational study within 30 days prior to surgery.
Cardiogenic shock at the time of surgery.
Treatment with Clopidogrel and Ticagrelor within 5 days before surgery, Prasugrel within 7 days before surgery, glycoprotein IIb/IIIa receptor blockers within 24 hours of surgery.
Treatment with new oral anticoagulants (Apixaban, Rivaroxaban, Dabigatran) within 48 hours before surgery.
surgery, radiation, or immunosuppressants within 28 days
Patients with a non-melanomatous, in situ malignancy or disease that is completely resectable with surgery may be considered after discussion with the Medical Monitor
After definitive surgery, e.g.
Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
Recent major surgery or trauma, unhealing/open wounds.
All known lesions were previously treated with surgery or stereotactic surgery (whole-brain radiation is not allowed unless given after definitive treatment with surgery or stereotactic surgery) AND
Placement of an intraperitoneal port at the time of surgery for anticipated use for adjuvant chemotherapy or management of post-operative ascites
Be candidates for clinical resection but for whom surgery is not urgently indicated (eg, for whom surgery within the next 2-4 months is appropriate).
Have had radiation within 6 months of the first dose of AG-120 or AG-881. (Note: Prior biopsy or surgery is allowed.)
Patients must have had 1 attempt at optimal debulking surgery.
Surgery (except minor surgeries,e.g., biopsies) or radiotherapy
Has at least one or more intraoperative visible air leak >= 2 mm following the lung resection surgery
Cardiac valvular surgery or open heart surgery
If a patient has had surgery prior to enrolling on study, an enhanced MRI or CT scan should be done within 96 hours prior to surgery or at least 4-6 weeks after surgery
No evidence of macroscopic disease following surgery
Surgery or invasive procedure requiring sutures or staples for closure =< 7 days prior to registration
Negative urinalysis within 30 days prior to date of surgery
Extensive pelvic exenteration surgery, surgeries which include partial or total vaginectomy with or without reconstruction; radical vulvectomy with or without remove of clitoris
Women who are currently undergoing or planning to undergo reconstruction surgery during the course of the study; women who have completed reconstruction surgery must be 30 days from surgery
Anticipating surgery, history of hypothyroidism, profound anemia (hemoglobin level of < 10 g/dL =< 28 days prior to registration), or clinical depression per physician discretion
Patient must consent for the appropriate surgery
Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
Has undergone immediate reconstructive surgery with placement of a tissue expander or permanent implant at time of mastectomy
Patients scheduled for surgery at Josie Robertson Surgery Center (JRSC)
Elective surgery anticipated during, pre-, or post-intervention period (e.g., breast reconstruction)
Patients with surgery for osseous metastases are allowed
Is eligible for definitive CRT and not considered for primary surgery based on investigator decision
Revision surgery in women at least 18 years old with surgically absent breast tissue (previous reconstruction with silicone-filled or saline-filled implants or revision reconstruction requiring expansion surgery prior to surgery for study device implantation, with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement)
No planned reconstructive surgery with flap repair during trial and follow-up period
Are planning reconstructive surgery with flap repair during trial and follow-up period
No surgery planned in the next 6 months
Patient must be willing to receive Nestle IMPACT Advance Recovery for five days prior to planned surgery as well as for 5 days after surgery
Admitted for surgery lasting > 1 hour and requiring urinary catheter
Plastic surgery involvement for oncoplastic reconstruction
If surgery is likely greater than 3 hours
Subjects that have had prior breast reduction surgery
Reconstructive surgery
Other conditions may exclude participants from the study (e.g. intractable nausea/emesis, allergic reaction to shake, patient decides not to have surgery, any medical condition that prevents patient from having surgery)
No surgery planned in the next 6 months
Prior surgery of the sacrum
Patients taking anti-coagulants or other blood thinning medications prior to surgery during the specified time frames:\r\n* Low molecular weight heparin less than 36 hours prior to surgery\r\n* Coumadin less than 5 days prior to surgery\r\n* Plavix and NSAIDs less than 7 days prior to surgery
Patients on any anti-seizure medications, such as gabapentin or Lyrica, specifically for chronic management less than 24 hours prior to surgery
Patients on Celebrex less than 24 hours prior to surgery
Require prone positioning for surgery
Patient has successfully lost 5% of body weight in the previous 6 months or has had bariatric surgery
Most recent INR prior to surgery > 1.4
Prior H&N surgery excluding diagnostic procedures, transoral surgery, or non-radical neck dissection
Bone fracture/surgery of an extremity during the preceding 6 months
An interval of at least one year, but no more than five years, following the full completion of primary therapy for malignant disease; primary therapy is defined as:\r\n* Surgery plus radiation\r\n* Surgery plus chemotherapy\r\n* Surgery plus trastuzumab\r\n* Surgery plus hormone therapy\r\n** Note: For patients who receive hormone therapy following surgery, the definition of one-year post-completion of therapy is defined by the surgery date; patients who are currently receiving hormone therapy are eligible for enrollment
Treated with chemotherapy and surgery
Additional surgery at the same time as RC (e.g. nephroureterectomy)
Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) that are each planned to receive a total of > 50 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.
Serum creatinine < 1.5 measured within 30 days of surgery
Patients who have had mastectomy with reconstructive surgery in one or both breasts
Planned surgery anticipated during the intervention period
The patient is not indicated for Mohs surgery
Positive antibody titers to BMP-2, bovine collagen, or BMP-2 neutralizing antibodies prior to surgery
Mastectomy is the surgery performed
Physiologic suitability for major abdominal surgery
Benign or oncologic indications for surgery
Open laparotomy or laparoscopic surgery undertaken with cancer therapeutic intent (not a subsequent surgery to manage a postoperative complication) that had occurred =< 7 days prior to registration and that entailed more than a simple hysterectomy
Patients participating in a meditation practice more often than 1 hour per week prior to surgery and/or chemotherapy administration
Patients must not have a history of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to registration
Sphincter-preserving surgery and >= 12 months after restoration of bowel continuity
Prior sacral/lower spinal surgery
No blood?thinning medications, including anti?inflammatory medications, herbs and supplements for at least 1 week prior to surgery
Subjects will include women who are being seen at the Women's Health Center by the Gynecological Oncology group at the University of Minnesota (UMMC). These women will be considered for inclusion based on their projected surgery: exploratory laparotomy. Subjects will have to have their surgery at the UMMC within 1 month of their clinic visit. Patients may be undergoing surgery for either known cancer (ovarian or uterine) or high suspicion for malignancy.
if they are currently using or planning on using other complementary alternative medicine (CAM) therapies prior to or after surgery.
At least 3 weeks since formal exploratory thoracotomy and patient has recovered from surgery, or 1 week from diagnostic thoracoscopy
Prior extensive pelvic surgery such as low anterior resection, abdomino-perineal resection, or proctocolectomy continent stool pouch, or any other extensive abdomino-pelvic surgery that would render the patient high-risk for complications as deemed by the surgeon
Demonstrated intra-operative anastomotic leakage when irrigated with 120 mL of normal saline at the end of surgery
Subjects may or may not have had surgery (lumpectomy or mastectomy) prior to RT; (NOTE: surgery is not required for eligibility)
Planned outpatient surgery
Contraindicated for surgery.
Prolonged chest infection, defined as lung consolidation that requires hospitalization and greater than 10 days of antibiotics 30 days prior to surgery.
> 8 weeks removed from surgery to treat endometrial cancer
Patients must have stage I-III colon or rectal cancer and have undergone definitive therapy; definitive therapy may have included surgery alone, or surgery plus neoadjuvant and/or adjuvant therapy
Previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts surgery foreseen in the near future, or ocular disease leading to visual loss
Prior open or laparoscopic/robotic bladder or prostate surgery
Patients with any breast surgery or biopsy within 90 days prior to the study
Patients with any breast surgery or biopsy within 90 days prior to the study
Safe for surgery per treating neurosurgeon
Individuals with prior bariatric surgery procedures
History of gastric surgery
Patients with a history of gastric bypass surgery
Prior or planned bariatric surgery
PILOTS I, II AND III: Less than 3 months post-surgery
Any prior surgery to the prostate within 30 days of baseline procedures; NOTE: Biopsies are not considered surgeries
Inclusion Criteria:\n\n          1. Scheduled to undergo elective colon and/or rectal surgical procedures involving open\n             laparotomy, hand-assisted laparoscopy, and laparoscopic-assisted approaches. The\n             principal incision must have a length of > 5 cm and < 35 cm in length.  Eligible\n             surgeries are: left hemicolectomy, right hemicolectomy, transverse colectomy,\n             ileocolic resection, total abdominal colectomy with ileorectal anastomosis, total\n             abdominal proctocolectomy (portion of specimen to be extracted via laparotomy), low\n             anterior resection, sigmoid resection, non-emergent Hartmann procedure, colostomy\n             takedown through laparotomy (not peristomal) incision, ileo-pouch anal anastomosis,\n             and abdominal perineal resection of the rectum.\n\n          2. Able to give informed consent.\n\n          3. Male or female ?18 years of age.\n\n          4. If female, is non-pregnant (negative pregnancy test result at the\n             Screening/Randomization Visit) and non-lactating.\n\n          5. If female, is either not of childbearing potential (defined as postmenopausal for at\n             least 1 year or surgically sterile [status post bilateral tubal occlusion, bilateral\n             oophorectomy, or hysterectomy]) or practicing 1 of the following methods of birth\n             control and agrees to continue with this regimen over the study surveillance period:\n\n               -  Oral, implantable, or injectable contraceptives for 3 consecutive months before\n                  the Baseline/Randomization Visit\n\n               -  Intrauterine device\n\n               -  Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or\n                  cream)\n\n               -  Not sexually-active. Agreement to be available for evaluation at the study site\n                  for scheduled visits.\n\n        Exclusion Criteria:\n\n          1. Hypersensitivity to porcine products.\n\n          2. History of known anti-myeloperoxidase autoantibodies (i.e., pANCA), as well as\n             patients with known idiopathic necrotizing glomerulonephritis and certain systemic\n             vasculitis conditions [e.g., microscopic polyangiitis of small blood vessels,\n             Wegener's granulomatosis, and Churg-Strauss Syndrome]).\n\n          3. Use of microbial sealant (IntegusealTM), any antibiotic-embedded suture, or any\n             antimicrobial-embedded suture to close the principal incision or any suture in the\n             surgical field that has not been formally approved by the relevant local national\n             regulatory authority.\n\n          4. Absolute contraindication to general anesthesia.\n\n          5. Hypersensitivity reactions to steri-strip tapes, medical-surgery tapes, adhesives, or\n             sutures. (Note: If there can be assurances that the subject will not be exposed to\n             these materials that cause hypersensitivity, alternatives will be allowed.)\n\n          6. History of keloid or hypertrophic scarring within or near an incision from a prior\n             surgery.\n\n          7. Body mass index [BMI]: > 50 or < 20 (both due to the extremely high risk of poor\n             wound healing).\n\n          8. ASA score > 3.\n\n          9. Undergoing emergency colorectal surgery such that standard bowel preparation and\n             other standard preoperative precautions and assessments cannot be performed in time\n             before the index-surgery.\n\n         10. The planned index-surgery involves removal or placement of mesh (either synthetic or\n             biological) as part of closure in the principal incision or traversing any part of a\n             pre-existing mesh (either synthetic or biological) in the principal incision.\n\n         11. There are clinical signs of overt infection necessitating systemic antibiotics via\n             oral, intramuscular, or intravenous routes (e.g., infection of the abdominal wall,\n             peritonitis, pneumonia, and sepsis/septic shock) prior to the index-surgery.\n\n         12. Preoperative severe neutropenia (total neutrophil count ?500 X 109/L).  (Note:\n             Testing should be performed at the local laboratory.)\n\n         13. Receiving any oral or intravenous antibiotics within 24 hours prior to the\n             index-surgery. (Note: It is permissible to administer conventional oral prophylactic\n             antibiotics as bowel preparation up to the time of the index- surgical procedure, as\n             well as intravenous or intramuscular prophylactic antibiotics just prior to the\n             index-surgery as per the treating surgeon's standard of care.)\n\n         14. Preoperative evaluation that the intra-abdominal process might preclude full closure\n             of the skin incision due to severe or morbid obesity (i.e., any mechanical reason\n             that would prevent/preclude primary intent wound healing) at the principal in
Inclusion Criteria:\n\n          1. Scheduled to undergo elective colon and/or rectal surgical procedures involving open\n             laparotomy, hand-assisted laparoscopy, and laparoscopic-assisted approaches. The\n             principal incision must have a length of > 5 cm and < 35 cm in length.  Eligible\n             surgeries are: left hemicolectomy, right hemicolectomy, transverse colectomy,\n             ileocolic resection, total abdominal colectomy with ileorectal anastomosis, total\n             abdominal proctocolectomy (portion of specimen to be extracted via laparotomy), low\n             anterior resection, sigmoid resection, non-emergent Hartmann procedure, colostomy\n             takedown through laparotomy (not peristomal) incision, ileo-pouch anal anastomosis,\n             and abdominal perineal resection of the rectum.\n\n          2. Able to give informed consent.\n\n          3. Male or female ?18 years of age.\n\n          4. If female, is non-pregnant (negative pregnancy test result at the\n             Screening/Randomization Visit) and non-lactating.\n\n          5. If female, is either not of childbearing potential (defined as postmenopausal for at\n             least 1 year or surgically sterile [status post bilateral tubal occlusion, bilateral\n             oophorectomy, or hysterectomy]) or practicing 1 of the following methods of birth\n             control and agrees to continue with this regimen over the study surveillance period:\n\n               -  Oral, implantable, or injectable contraceptives for 3 consecutive months before\n                  the Baseline/Randomization Visit\n\n               -  Intrauterine device\n\n               -  Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or\n                  cream)\n\n               -  Not sexually-active. Agreement to be available for evaluation at the study site\n                  for scheduled visits.\n\n        Exclusion Criteria:\n\n          1. Hypersensitivity to porcine products.\n\n          2. History of known anti-myeloperoxidase autoantibodies (i.e., pANCA), as well as\n             patients with known idiopathic necrotizing glomerulonephritis and certain systemic\n             vasculitis conditions [e.g., microscopic polyangiitis of small blood vessels,\n             Wegener's granulomatosis, and Churg-Strauss Syndrome]).\n\n          3. Use of microbial sealant (IntegusealTM), any antibiotic-embedded suture, or any\n             antimicrobial-embedded suture to close the principal incision or any suture in the\n             surgical field that has not been formally approved by the relevant local national\n             regulatory authority.\n\n          4. Absolute contraindication to general anesthesia.\n\n          5. Hypersensitivity reactions to steri-strip tapes, medical-surgery tapes, adhesives, or\n             sutures. (Note: If there can be assurances that the subject will not be exposed to\n             these materials that cause hypersensitivity, alternatives will be allowed.)\n\n          6. History of keloid or hypertrophic scarring within or near an incision from a prior\n             surgery.\n\n          7. Body mass index [BMI]: > 50 or < 20 (both due to the extremely high risk of poor\n             wound healing).\n\n          8. ASA score > 3.\n\n          9. Undergoing emergency colorectal surgery such that standard bowel preparation and\n             other standard preoperative precautions and assessments cannot be performed in time\n             before the index-surgery.\n\n         10. The planned index-surgery involves removal or placement of mesh (either synthetic or\n             biological) as part of closure in the principal incision or traversing any part of a\n             pre-existing mesh (either synthetic or biological) in the principal incision.\n\n         11. There are clinical signs of overt infection necessitating systemic antibiotics via\n             oral, intramuscular, or intravenous routes (e.g., infection of the abdominal wall,\n             peritonitis, pneumonia, and sepsis/septic shock) prior to the index-surgery.\n\n         12. Preoperative severe neutropenia (total neutrophil count ?500 X 109/L).  (Note:\n             Testing should be performed at the local laboratory.)\n\n         13. Receiving any oral or intravenous antibiotics within 24 hours prior to the\n             index-surgery. (Note: It is permissible to administer conventional oral prophylactic\n             antibiotics as bowel preparation up to the time of the index- surgical procedure, as\n             well as intravenous or intramuscular prophylactic antibiotics just prior to the\n             index-surgery as per the treating surgeon's standard of care.)\n\n         14. Preoperative evaluation that the intra-abdominal process might preclude full closure\n             of the skin incision due to severe or morbid obesity (i.e., any mechanical reason\n             that would prevent/preclude primary intent wound healing) at the principal in
Participants with acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered
Participants with fundoplication within the past year, bariatric surgery or any other major upper gastrointestinal (GI) surgery; fundoplication more than one year ago will not be grounds for exclusion; cholecystectomy will not be grounds for exclusion
Individuals with a history of bariatric surgery or planned bariatric surgery within 2 years
Planned reconstructive surgery with flap repair during study period
Maximum 8-week interval from last chemotherapy administration or last breast surgery (whichever is more recent) to radiation
Patients who have received surgery alone or radiotherapy alone as definitive local therapy
Subject has an active ocular condition that in the opinion of the investigator may alter visual acuity during the course of the study (i.e., ocular inflammatory disease etc.) or a history or anticipation of major ocular surgery (including cataract extraction, intraocular surgery, etc.) during the study.
Medical comorbidities making surgery unsafe as determined by the patient’s surgeon
Patients who’ve received a therapeutic course of antibiotics within 15 days prior to thoracic surgery
History of surgery involving the luminal gastrointestinal (GI) tract, including bariatric surgery; exception: prior appendectomy is not an exclusion criterion
Definitive surgery being performed at MSKCC within 0-60 days of completing NAC
Surgery (mastectomy or BCT) planned within 60 days of the MRI
Subjects must be enrolled before starting chemoradiation, either pre -or post-surgery
Patients who are cleared for surgery
Operated for debulking, decompression or separation surgery
An MRI performed within 72 hours after surgery is needed
Plasma creatinine in excess of 180 umol/L within 30 days prior to surgery
Indications for stress testing is either: \r\n* As part of a pre-operative evaluation prior to a planned cancer related surgery that is considered to be at least of intermediate risk (Intra-peritoneal, intra-thoracic, head and neck surgery, orthopedic or prostate surgery) OR \r\n* As an evaluation in the cardiology clinic for symptoms described in a cardiology consult as typical angina, or of significant suspicion for coronary disease or symptoms described as likely of a cardiac/coronary etiology
Prior anti-incontinence surgery
Subjects expecting to undergo surgery between the imaging sessions; subjects may undergo surgery at any time before the first, or after the last imaging session; this exclusion only applies to each study visit (3 day scanning session), and does not apply to the time (at least 3 weeks) between each study visit
Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been performed since enrollment into the BDS-USHPV study
Patients with newly diagnosed glioblastoma multiforme (GBM) and one of the following options:\r\n* Eligible for surgery after the last research scan\r\n* Significant residual disease after initial surgery\r\n** The principal investigator or co-PI must review MRI and CT findings and agree with the presence of significant residual disease\r\n* Treatment (non-surgical) naive
Patient desire to undergo breast surgery
Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
Prior resection surgery is allowable.
Patients not receiving breast surgery care from the Department of Breast Surgery at Columbia Medical Center
No recent chemotherapy or surgery, as defined as in the last 6 months
Electronic version of pre-surgery MRI must be available for co-registration purposes
Be contraindicated for surgery
Attempted maximal cytoreductive surgery; patients will still be eligible whether optimal or suboptimally debulked at the completion of the surgery
Patients who had prior major gastrointestinal surgery removing part of gastrointestinal tract and/or gall bladder.
Being treated with definitive chemoradiotherapy or surgery
Patient opted for robotic (da Vinci robot) or laparoscopic surgery
Previous exposure to OTL38 2. Known FR-negative ovarian cancer 3. Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy.
Timing of surgery: Must be anticipated to take place at least 1 hour after BLZ-100 administration
Patients who require surgery sooner than 28 days from enrollment
Planned surgical approach via laparoscopy or robotic surgery
Subjects must be sufficiently healthy to undergo surgery or an endoscopic procedure.
Women who have declined or otherwise not received preceding surgery