CT or MRI within 14 days prior to start of study drug
Evidence of metastatic breast cancer; patient considered at high risk of having disseminated disease (i.e. those with locally advanced disease, clinical N2-3 or pathological N1-3 with the exception of pN1a in adjuvant patients) should have a CT/MRI scan of the thorax/abdomen/pelvis or any other area as clinically indicated and a bone scan or a CT scan with bone windows at any point between diagnosis of the current breast cancer and randomization to rule out metastatic breast cancer; (note PET/CT scan may be used as an alternative imaging technique and precludes the need for bone scan); patients with screening ALT/AST or ALP above institutional upper limit of normal should have liver ultrasound, CT or MRI at any time point between diagnosis of current breast cancer and randomization; screening bone scan is required if ALP and/or corrected calcium level are above the institutional upper limit; (note PET CT scan may be used as an alternative imaging technique)
Patients must have shown unequivocal radiographic evidence for tumor progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan; if an MRI is being obtained to verify eligibility, it is recommended that the MRI parameters follow the specifications detailed in the protocol so that the patient will not require a repeat MRI prior to treatment start
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: \r\n* They have recovered from the effects of surgery\r\n* A minimum of 28 days have elapsed from the day of surgery to the day of registration step 2; for core or needle biopsy, a minimum of 7 days must have elapsed prior to registration step 2\r\n* Residual disease following resection of recurrent ependymoma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to consent; if the \within 96-hour after surgery\ scan is more than 14 days before consent, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and consent, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days
There must be documentation by PET/CT scan, CT scan, or MRI, that the patient has evidence of measurable metastatic disease per RECIST 1.1.
Magnetic resonance imaging (MRI) (or computed tomography [CT] if MRI contraindicated) within 14 days prior to start of study drug; corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan; if steroids are added or the steroid dose is increased between the date of the screening MRI or CT scan and the start of treatment, a new baseline MRI or CT is required
Patients must have an unequivocal progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan; a scan must be performed within 14 days prior to registration and on a steroid dose that has been stable or decreasing for at least 5 days; if the steroid dose is increased between the date of imaging and initiation of study treatment, a new baseline MRI/CT is required
CT or MRI of the neck to confirm staging
Measurable disease by CT or MRI
No definitive evidence of metastases on screening CT or MRI of abdomen/pelvis and radionuclide whole body bone scan per the judgment of the investigator. Abdominal and/or pelvic lymph nodes measuring 2 cm or less in short axis diameter are allowed. Lesions identified on other imaging modalities (e.g. PSMA or choline PET) that are not visualized on CT and/or MRI or radionuclide bone scan are allowed. Equivocal lesions on bone scan should be followed up with additional imaging as clinically indicated.
Patients must have prior CT scan images available for investigators to collect
Unequivocal evidence of tumor progression as documented by biopsy or brain MRI scan per Revised Assessment in Neuro-Oncology (RANO) criteria
MRI-guided cryoablation criteria-cohort 1: \r\n* Participants must have a mass that is well-visualized under MRI; since PET-CT guidance requires the nuclear medicine department to administer a radionuclide material, either fluorodeoxyglucose (FDG) or a somatostatin analog (DOTATATE), the default will be to try to use MRI guidance which will be simpler
Patient has one or more metastatic tumors measurable per RECIST 1.1 by CT scan ?4 weeks prior to entry into the study
Metastatic disease by bone scan or other nodal or visceral lesions on CT or MRI at any time (past or present).
At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment
Measurable disease detected by imaging exam (CT or MRI).
Stenosis or occlusion in intended artery for treatment that precludes IA therapy as determined by CT or MRI
Inability to exclude major side branches in the area of the intended RenovoCath™ occlusion as determined by CT or MRI
No suitable artery with a diameter greater than 4mm in proximity of at least one side of the tumor as determined by CT or MRI
Patients must have measurable disease, defined as tumor mass which is > 10 mm with spiral CT scan or MRI. Baseline imaging scan must be within 8 weeks of registration.
Patients who are not able to receive an MRI scan
No radiographic evidence of metastatic disease by computed tomography (CT) scan and bone scan, performed within the prior 4 weeks
For subjects enrolled for tumor progression, progression is defined as: \r\n* Presence of new plexiform neurofibroma on MRI or computed tomography (CT) (documented by comparison with prior MRI or CT), OR \r\n* A measurable increase in plexiform neurofibroma size (>= 20% increase in the volume, or a >= 13% increase in the product of the two longest perpendicular diameters, or a >= 6% increase in the longest diameter) documented by comparison of two scans (MRI or CT) in the time period of approximately one year or less prior to evaluation for this study
Patient must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
Participants must have shown unequivocal evidence for tumor progression by MRI or computed tomography (CT) scan
CT or MRI within 14 days prior of registration; NOTE: participants may be registered if screening CT or MRI is > 14 days of registration if prospective approval is received from overall principal investigator (PI), Dr. Patrick Wen (for prospectively approved circumstances an eligibility exception will not need to be filed)
Patients having undergone recent resection of recurrent or progressive tumor will be eligible given all of the following conditions apply:\r\n* At least 2 weeks (14 days) have elapsed from the date of surgery and the patients have recovered from the effects of surgery\r\n* Evaluable or measurable disease following resection of recurrent malignant glioma is not mandated for eligibility into the study\r\n* To best assess the extent of residual disease post-operatively, a magnetic resonance imaging (MRI) should be done no later than 96 hours in the immediate post-operative period or at least within 4 weeks post-operatively, within 14 days prior to registration; if the 96-hour scan is more than 14 days before registration, the scan needs to be repeated; the patient must have been on a stable steroid dose for at least 5 days prior to the baseline MRI; steroids may be initiated as clinically indicated once baseline imaging has been completed with a goal of titrating steroids as soon as clinically warranted
Locally advanced rectal cancer determined by any of the following features\r\n* Fixed or immobile tumor on physical exam and/or\r\n* T3 disease with invasion through the muscularis propria as defined by transrectal ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI)\r\n* T4 disease with invasion of adjacent structures such as pelvic sidewall, sacrum, pelvis, bladder and/or prostate as determined appropriate imaging modalities such as ultrasound, CT or MRI\r\n* Any T with + N on CT scan/MRI or transrectal ultrasound
Distant metastases, based upon:\r\n* CT scan or MRI of the abdomen/pelvis within 120 days prior to registration and\r\n* Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis prior to registration
Patients must have had radiographic evidence of tumor progression by brain MRI or computed tomography (CT) scan with contrast
Evidence of > grade 1 CNS hemorrhage on baseline MRI on CT scan
Prostate volume: =< 80 cc on transrectal ultrasound\r\n* Measured from ultrasound, CT, or MRI within 3 months
MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
At least one site of measurable disease on x-ray/CT/MRI scan as defined by RECIST 1.1
FOR ARM A: Inability to obtain a planning MRI or a planning MRI of sufficient quality to allow identification of the peripheral zone and urethra, or inability to adequately fuse the MRI to the planning CT scan
Subjects who have minimal CT scan findings suspicious of residual disease are eligible provided there is no evidence of progression of disease by Rustin Criteria, defined as: \r\n* Present CT Scan findings show no change from CT Scan at baseline, and\r\n* Current CA-125 is below institutional upper normal limit and remains unchanged upon two consecutive measurements at least one week apart, and\r\n* CA-125 was above institutional upper normal limit at diagnosis
Equivalent tumor diameter =< 40 mm by CT or MRI measurement, at the time of consultation/screening (for each metastatic lesion present in the brain)
Patient must have had a diagnosis of high risk NB at initial diagnosis or if non-high risk at time of initial diagnosis must have had evidence of metastatic progression when > 18 months of age\r\n* Patient must have measurable or evaluable disease occurring as one of the following:\r\n** Disease progression after initiation of upfront NB therapy defined as:\r\n*** New disease site documented on MIBG scintigraphy; or computed tomography (CT)/magnetic resonance imaging (MRI); or any new bone site that is fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) avid (in patient known to have MIBG non-avid tumor) AND has MRI findings consistent with tumor OR has a biopsy showing NB or ganglioneuroblastoma\r\n*** Greater than 20% increase in a least one dimension of soft tissue mass documented by CT/MRI AND a minimum absolute increase of 5 mm in longest dimension in existing lesions\r\n*** Bone marrow biopsy meeting revised International Neuroblastoma Response Criteria (INRC) criteria for progressive disease\r\n** Refractory disease such that response to upfront therapy (defined as at least 4 cycles of multi-agent induction chemotherapy) is less than partial response\r\n** Persistence of disease after at least a partial response to frontline therapy (i.e. patient has had at least a partial response to frontline therapy but still has residual disease by MIBG scan, CT/MRI, or bone marrow aspirate/biopsies); patients in this category are REQUIRED to have histologic confirmation of viable NB from at least one residual site; tumor seen on routine bone marrow morphology is sufficient
No distant metastases, based upon:\r\n* CT scan or MRI of the pelvis within 120 days prior to registration\r\n* Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis
Measurable tumor on MRI or CT scan or X-ray
Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis
Patients deemed as resectable by pancreatic protocol CT or MRI
Patients with histologically proven intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma will be eligible. Patients must have shown unequivocal radiographic evidence for tumor progression by MRI scan. A scan should be performed within 14 days prior to registration and on a steroid dose that has been stable for at least 5 days. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI is required.
Cranial magnetic resonance imaging (MRI) or contrast computed tomography (CT) must have been performed within 21 days of study entry; the use of MRI rather than CT is preferred; the same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement; if the surgical procedure was a resection, cranial MRI or contrast CT performed within 96 hours of resection is preferred but not required; if the surgical procedure was a biopsy only, a head CT within 96 hours of the biopsy is acceptable; patients without measurable or assessable disease are eligible
Patients must have shown unequivocal radiographic evidence for tumor progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan; a scan should be performed within 14 days prior to registration and on a steroid dose that has been stable or decreasing for at least 5 days; if the steroid dose is increased between the date of imaging and registration a new baseline MRI/CT is required; the same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement; measurable disease is NOT required\r\n* Note: MRI is the preferable imaging method; CT scan may be used in cases where an MRI cannot be obtained
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:\r\n* They have recovered from the effects of surgery and be > 3 weeks from surgery\r\n* Residual disease following resection of recurrent malignant glioma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to registration; if the 96-hour scan is more than 14 days before registration, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days
Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and MRI of the liver) must be performed within 28 days prior to randomization. An MRI of the liver is required at screening to validate that CT accurately reflects the extent of disease in the liver. For patients with MRI intolerance, a 3-phase liver CT is to be done in place of liver MRI.
Patients with evidence on prior imaging (bone scan, CT, or MRI) suggestive of disseminated disease will not be eligible (imaging not required for eligibility)
No space occupying lesion on computed tomography (CT) scan of the liver i.e. normal CT scan post-resection; small lesion in the liver after resection can be ablated by alcohol injection or radio frequency ablation and can make patient eligible
Tumour stage cT1-T3abN0 based on pelvic MRI
Baseline staging prior to chemoRT initiation must be obtained. If stage IV, there must be documentation by PET/CT scan, CT scan, or MRI, that the patient has evidence of measurable distant disease per RECIST 1.1. Note: Patients with stage IV disease should have limited but measurable metastatic disease (one or two organs involved e.g., liver and lung) and primary tumor deemed resectable.
RANO defined tumor progression by MRI in comparison to a prior scan
Measurable disease by CT or MRI.
Subjects must not have evidence of pneumonitis or inflammatory lung disease on CT scan and x-ray
Computed tomography (CT) scan and MRI of the pelvis within 120 days prior to enrollment (note: [a] if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed [b] for patients with PSA < 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan)
Patients with non-measurable disease < 10 mm on multiparametric MRI or CT scan will be excluded
Participants must have shown unequivocal evidence for tumor progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan\r\n* For Cohort 2 subjects, CT or MRI within 14 days prior to study registration; for Cohort 2, corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan; if steroids are added or the steroid dose is increased between the date of the screening MRI or CT scan and the start of treatment, a new baseline MRI or CT is required\r\n* For Cohort 1 subjects, CT or MRI should be performed ideally within 14 days prior to study registration, it is acceptable for this MRI/CT to have been performed greater than 14 days prior to registration if unavoidable; furthermore, fluctuation in corticosteroid dose around this MRI does not warrant repeat scan so long as there is documented unequivocal evidence of tumor progression available
Participants having undergone recent resection or open biopsy or stereotactic biopsy of recurrent or progressive tumor will be eligible for Cohort 2 as long as the following conditions apply:\r\n* They have recovered from the effects of surgery\r\n* Residual disease following resection of recurrent tumor is not mandated for eligibility; to best assess the extent of residual disease post-operatively, an MRI or CT scan should ideally have been performed no later than 96 hours following surgery, or at least 28 days post-operatively, but scans performed outside of this window are considered acceptable if no alternative is available; in either case, the baseline/screening MRI must be performed within 14 days prior to registration; if the participant is taking corticosteroids, the dose must be stable or decreasing for at least 5 days prior to the scan; if steroids are added or the steroid dose is increased between the date of the screening MRI or CT scan and the start of treatment, a new baseline MRI or CT is required
The tumor must be clinically determined to be locally advanced stage II or stage III rectal cancer, and must also meet any ONE of the following criteria:\r\n* Distal location (as defined by measurement on magnetic resonance imaging [MRI], transrectal ultrasound [ERUS]/pelvic computed tomography [CT] [with IV contrast] scan or palpable on digital rectal examination [DRE]): cT3-4 =< 5 cm from the anal verge, any N\r\n* Bulky: any cT4 or evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on MRI or ERUS/pelvic CT (with IV contrast) scan\r\n* High risk for metastatic disease with 4 or more regional lymph nodes (cN2); clinical nodal or \cN\ status for eligibility includes the total number of nodes (N2 = 4 or more) in the mesorectal and superior rectal stations measuring >= 1.0 cm in any axis on cross sectional or endoscopic imaging; Note: nodes must measure 1.0 cm or greater to be considered positive for this eligibility requirement\r\n* Not a candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy (as planned by the primary surgeon)\r\n** Note: clinical stage of the primary tumor and nodes may be determined locally by rectal endoscopic ultrasound or pelvic MRI (MRI is strongly preferred); CT scan with IV contrast is acceptable provided there is evidence of T4 and/or N2 disease
Positive indication of disease on mammogram or MRI scan
A pre-operative magnetic resonance imaging (MRI) scan of the brain with and without contrast is required; NOTE: computed tomography (CT) scans are NOT sufficient for study eligibility\r\n* Post-operative head MRI scan with and without contrast (preferably within 72 hours post-surgery); for patients who undergo stereotactic biopsy only, either a pre or post-operative MRI is sufficient; for patients with M2 and M3 disease, a post-op MRI is strongly encouraged, but not mandatory\r\n* Spinal MRI imaging with and without gadolinium is required within 10 days of surgery if done pre-operatively or within 28 days of surgery if done post-operatively; for posterior fossa tumors, pre-operative MRI scans are preferred
Evidence of any significant intracranial hemorrhage, as determined by the treating investigator, within 6 weeks from registration or as seen on most recent MRI prior to screening/baseline MRI
One or more tumors measurable on CT scan/MRI scan per RECIST v 1.1. - Previously irradiated tumors may be eligible if they have clearly progressed in size.
Measurable disease by CT or MRI
Patients with glioma must have a baseline brain MRI scan
Glioma patients with evidence of intracranial or intratumoral hemorrhage either by MRI or CT scan
No new bleeding on day 28 (D28) (+/-3) MRI (or CT if MRI is contraindicated)
Evidence of CNS hemorrhage on baseline MRI or CT scan (except for post-surgical, asymptomatic Grade 1 hemorrhage that has been stable for at least 3 months for subjects enrolled prior to Amendment 2 and for at least 4 weeks in subjects enrolled after Amendment 2 is approved).
Patients must have a contrast enhanced CT scan or MRI or PET/CT scan of the tumor site and neck nodes prior to entering the study.
CT scan or Ultrasound-based volume estimation of prostate gland ? 100 grams;
CT scan that demonstrates no evidence of disease (NED) after completion of adjuvant therapy Note: This CT scan will also be used for Texture analysis.
Patients with radiographic evidence of metastatic prostate cancer (stage M1 or D2). Distant metastases evaluable by radionuclide bone scan, CT scan, or MRI within 28 days before the start of study treatment.
Participants must have a progression by MRI or computed tomography (CT) scan; a scan must be performed within 21 days prior to cycle 1, day 1 (C1d1) and on a steroid dose that has been stable for at least 5 days; if the steroid dose is increased between the date of imaging and C1d1, a new baseline MRI/CT is required; the same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement; a patient who develops a contraindication to undergo an MRI scan during study treatment may remain on study and undergo contrast enhanced CT scans
Measurable disease on CT or MRI scan by RECIST criteria (required for Phase 1b only).
Patients should undergo a repeat MRI prior to enrollment if there is a significant worsening or new neurologic symptoms in the interval between the eligibility scan and start of protocol therapy\r\n* The repeat scan will act as a new baseline and the eligibility scan for these patients
Measurable disease by CT or MRI
CT or MRI within 14 days prior to start of study drug; MRIs should include vascular imaging when possible; corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan; if steroids are added or the steroid dose is increased between the date of the screening MRI or CT scan and the start of treatment, a new baseline MRI or CT is required
Participants having undergone recent resection of recurrent or progressive tumor will be eligible as long as the following conditions apply:\r\n* They have recovered from the effects of surgery\r\n* Residual disease following resection of recurrent tumor is not mandated for eligibility; to best assess the extent of residual disease post-operatively, an MRI or CT scan should be done no later than 96 hours following surgery or at least 4 weeks post-operatively, in either case within 14 days prior to start of study drug; if the participant is taking corticosteroids, the dose must be stable or decreasing for at least 5 days prior to the scan; if steroids are added or the steroid dose is increased between the date of the screening MRI or CT scan and the start of treatment, a new baseline MRI or CT is required
Patients must have shown unequivocal evidence for contrast enhancing tumor progression by MRI (or CT for patients who cannot tolerate MRI) in comparison to a prior scan; the same type of scan, i.e., MRI (or CT for patients who cannot undergo MRI) must be used throughout the period of protocol treatment for tumor measurement; criteria defined for progression on this study are not mandatory for eligibility if the disease progression is obvious in the opinion of the investigator and the Sponsor
An MRI/CT scan showing progression is required; stable corticosteroids are not required
For subjects enrolled for tumor progression, progression is defined as:\r\n* Presence of new plexiform neurofibroma on MRI or computed tomography (CT) (documented by comparison with prior MRI or CT), OR\r\n* A measurable increase in plexiform neurofibroma size (>= 20% increase in the volume, or a >= 13% increase in the product of the two longest perpendicular diameters, or a >= 6% increase in the longest diameter) documented by comparison of two scans (MRI or CT) in the time period of approximately one year or less prior to evaluation for this study
Detectable metastases by bone scan, CT-scan or MRI
There must be documentation by PET/CT scan, CT scan, or MRI, that the patient has evidence of measurable metastatic disease per RECIST criteria.
At least one site of measurable disease on CT/MRI scans as defined by RECIST 1.1. Baseline imaging must be performed within 30 days of dosing.
Patients must have shown unequivocal radiographic evidence for tumor progression by MRI or CT scan; a scan should be performed within 14 days prior to registration and on a steroid dose that has been stable or decreasing for at least 5 days; if the steroid dose is increased between the date of imaging and registration a new baseline MR/CT is required; the same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:\r\n* They have recovered from the effects of surgery and be > 28 days from surgery\r\n* Residual disease following resection of recurrent GBM or GS is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to registration; if the 96-hour scan is more than 14 days before registration, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days
Unequivocal evidence of tumor progression by MRI scan
Histologically confirmed, metastatic prostate cancer (positive bone scan and/or measurable disease on CT scan and/or MRI of the abdomen and pelvis).
Radiographic evidence of metastatic disease, detectable by bone scan, CT scan, or MRI. At least one site of metastatic disease must be amenable to needle biopsy.
A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days (preferably 14 days) prior to C1D1.
Unresectable, locally advanced measurable (at least bidirectional) adenocarcinoma of the pancreas (regardless of site) proven by biopsy or cytology and confirmed by surgical consultation\r\n* Unresectability is defined as dual phase CT or magnetic resonance imaging (MRI) evidence of direct extension to the superior mesenteric artery (SMA) and/or celiac axis with absence of a fat plane between the low-density tumor and these arterial structures, or loss of patent and/or thrombosed superior mesenteric-portal vein confluence; if CT or MRI performed at the outside hospital is not of acceptable quality according to review of study radiologist (i.e. if it is not a triple phase contrast-enhanced CT with isotropic reformations in all three orthogonal planes, or a contrast-enhanced MRI with at least two post-contrast three-dimensional T1-weighted phases), it will be repeated at Indiana University Simon Cancer Center (IUSCC); if the CT or MRI is of sufficient quality for the study radiologist, a repeat interpretation will be done by the study radiologist to ensure accurate staging; CT scan will be preferred over MRI for study entry when possible, but either is permissible; the same study modality used for entry will be used to follow patients throughout the study\r\n* Patient has not received previous treatment for PC\r\n* Patients who have been surgically explored and deemed unresectable on that basis are eligible, provided other entry criteria are met\r\n* The tumor must be measurable (bidirectional) and measure between 25 mm and 70 mm in maximal diameter\r\n* All patients with a dilated bile duct or elevated total bilirubin will have a biliary stent or transhepatic stent placed before consideration for the trial; when possible, a metal biliary stent will be placed before study treatment
Histopathologically proven diagnosis of glioblastoma or variants (gliosarcoma, giant cell glioblastoma etc); patients will be eligible if the original histology was lower-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made\r\n* Patients who did not have recent surgery for their glioblastoma must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced MRI scan (or CT scan for patients with non-compatible devices) within 21 days prior to registration; Note: patients who did have surgery with a post-operative contrast-enhanced scan falling outside the 5-week window prior to registration, per definition of recent surgery, must have a repeat magnetic resonance imaging (MRI) scan (or computed tomography [CT] scan for patients with non-compatible devices) within 21 days prior to registration\r\n* Patients must have passed an interval of 6 months or greater between completion of prior radiotherapy and registration; if patients have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:\r\n** New areas of tumor outside the original radiotherapy fields as determined by the investigator, or\r\n** Histologic confirmation of tumor through biopsy or resection, or\r\n** Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of registration AND an interval of at least 90 days between completion of radiotherapy and registration\r\n* Patients unable to undergo MR imaging because of non-compatible devices can be enrolled provided CT scans are obtained and are of sufficient quality; patients without non-compatible devices may not use CT scans performed to meet this requirement
Patients having undergone recent resection of their glioblastoma (within 5 weeks prior to registration) must have recovered from the effects of surgery; for CNS related core or needle biopsies, a minimum of 7 days must have elapsed prior to registration\r\n* Residual disease following resection of recurrent glioblastoma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a post-operative or intra-operative MRI scan (or CT scan for patients with non-compatible devices) must be performed prior to registration and should be within 96 hours post surgery (although 24 hours would be optimum)
Only untreated patients with high risk pancreatic adenocarcinomas will be eligible for the study; for this study, such patients are defined as those who meet one or more of the following radiographic or serologic criteria:\r\n* Primary tumor that involves the superior mesenteric vein causing a vein deformity or segmental venous occlusion with a patent vessel above and below suitable for reconstruction\r\n* Primary tumor that involves =< 180 degrees of the superior mesenteric artery (SMA), celiac axis or any of its branches on CT or magnetic resonance imaging (MRI)\r\n* Primary tumor that abuts or encases (>= 50% of the vessel circumference) a short segment of the common hepatic artery (typically at the gastroduodenal artery origin)\r\n* Patients with a high cancer antigen 19-9 (CA19-9) (>= 500 mg/dl) in the presence of a bilirubin =< 2.0 mg/dL\r\n* Radiographic findings consistent with malignant peripancreatic lymphadenopathy outside the planned field on CT or MRI\r\n* Radiographic findings of indeterminate liver or peritoneal lesions on CT or MRI concerning but not diagnostic of metastatic disease
Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, MRI or laparotomy
No evidence of metastatic disease as determined by chest computed tomography (CT) scan, abdominal CT scan (or magnetic resonance imaging [MRI] with gadolinium and/or manganese) and staging laparoscopy; all patients must be staged with a physical exam, chest CT, abdominal CT with intravenous contrast (or abdominal MRI with gadolinium and/or manganese) and laparoscopy; only potentially resectable patients are eligible; potentially resectable is defined as \r\n* No extrapancreatic disease\r\n* No evidence (on CT) of involvement of the celiac axis or spinal muscular atrophy (SMA) \r\n* No evidence (CT or MRI) of occlusion of the superior mesenteric vein (SMV) or superior mesenteric-portal vein (SMPV) confluence, and \r\n* No evidence of gross peritoneal or distant metastases on staging laparoscopy or laparotomy
MRI scan with gadolinium contrast showing geographically-circumscribed tumor =< 40 cc incorporating both enhancing and non-enhancing volume; this is calculated by the product of maximum measurements in 3 dimensions divided by 2; tumors exceeding this limit may be eligible and any question should be directed to a radiation oncology investigatory and the MSK principal investigator (PI); (the MRI must be performed on a steroid dosage that has been stable or decreasing for at least 5 days; patients on no steroids are eligible; if the steroid dose is increased between date of imaging and registration, a new baseline MRI is required)
Glioma showing prior spontaneous hemorrhage as determined from the clinical history or from any preoperative computed tomography (CT) or MRI scan (excluding grade 1 punctate, incidentally found)
Inability to complete a MRI or CT scan with contrast of the head
Patients must have an unequivocal progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan; a scan must be performed within 14 days prior to registration and on a steroid dose that has been stable or decreasing for at least 5 days; if the steroid dose is increased between the date of imaging and first dose of plerixafor, a new baseline MRI/CT is required; the same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement; a patient who develops a contraindication to undergo an MRI scan during study treatment may remain on study and undergo contrast enhanced CT scans
For patients enrolled in Part 2 (surgical substudy), CT or MRI should be performed ideally within 14 days prior to study registration, but because the screening MRI for this subset of subjects will not be used for evaluation of response, it is acceptable for this MRI/CT to have been performed greater than 14 days prior to registration if unavoidable; furthermore, for this same reason, fluctuation in corticosteroid dose around this MRI does not warrant repeat scan so long as there is documented unequivocal evidence of tumor progression available
These laboratory values must be obtained within 28 days prior to registration; patients with levels of one or more of these enzymes greater than institutional upper limit of normal (IULN) may still be enrolled if metastatic disease is excluded with appropriate imaging which may include dedicated liver imaging, bone scan, PET, CT, MRI, or biopsy when appropriate
All active liver lesions must be discrete on CT or MRI imaging
Cranial MRI or contrast CT must have been performed within 21 days of study entry; the use of MRI rather than CT is preferred; the same type of scan, i.e., MRI or CT, must be used throughout the period of protocol treatment for tumor measurement; if the surgical procedure was a resection, cranial MRI or contrast CT performed within 96 hours of resection is preferred, but not required; patients without measureable or assessable disease are eligible
CT or MRI evidence of metastatic disease to the bone
No evidence of locoregional disease or distant metastases at screening. Subjects must have negative scans (CT, CT-PET or MRI) for locoregional recurrence, brain or lung metastases. A negative biopsy will be mandated in patients with a positive scan. Other evaluations should be performed as clinically indicated.
Metastatic Disease with at least one lesion on bone scan and/or soft tissue on CT/MRI
Every patient with relapse or progression into the CNS must be documented with computed tomography (CT) scan or MRI of the brain; other sites of relapse may be evaluated, including bone marrow
Cohort Expansion: One or more tumors measurable on CT/MRI scan per RECIST v 1.1 (Eisenhauer 2009; Appendix C).
Measurable disease by CT or MRI
Uneqivocal evidence of a first tumor recurrence or progression on the initial treatment regimen (prior to enrollment on this study), consisting of surgical intervention (biopsy and/or resection), radiation, and temozolomide chemotherapy, as assessed by MRI or CT scan of the brain with or without contrast within 14 days prior to the start of SL-701. If receiving corticosteroids, the dose must be stable or decreasing for at least 5 days prior to the scan. Patients unable to undergo MRI because of non-compatible devices can be enrolled, provided CT scans are obtained and are of sufficient quality. For each patient, the same imaging technique should be performed throughout the study, for purposes of assessing tumor response or PD.
No evidence of hemorrhage on the baseline MRI or CT scan other than those that are Grade ? 1 and either post-operative or stable on at least two consecutive scans.
For patients who have undergone or will undergo stereotactic biopsy of recurrent or progressive tumor, a post-operative magnetic resonance imaging (MRI) is not required, provided that the pre-biopsy MRI is within 21 days of registration; if the preoperative scan is more than 21 days before registration, the scan needs to be repeated; if the steroid dose is increased more than 50% between the date of biopsy and registration, a new baseline MRI is required on a stable or decreasing steroid dosage for at least 3 days even if the previous MRI was within 21 days of registration
For patients who have undergone or will undergo open resection of recurrent or progressive tumor, residual disease following resection is not mandated for eligibility into the study; to best assess the extent of residual disease post-resection, a MRI scan should be done no later than 96 hours in the immediate post-resection period and within 21 days prior to registration; if the 96-hour scan is more than 21 days before registration, the scan needs to be repeated; if the steroid dose is increased more than 50% between the date of imaging and registration, a new baseline MRI is required on a stable or decreasing steroid dosage for at least 3 days
Evidence of tumor progression by MRI or computed tomography (CT) scan following radiation therapy or following the most recent anti-tumor therapy; note: patients who have had surgical treatment at recurrence are eligible if they had a resection with measurable or non-measurable residual disease on postoperative imaging or if there is imaging evidence of disease progression as compared to the first postoperative scan
The presence of at least one lesion that can be accurately assessed at baseline by CT, MRI or plain X-ray and is suitable for repeated assessment. Estimated life expectancy of more than 12 weeks.
Residual disease following resection of recurrent tumor is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, an MRI should be done no later than 96 hours in the immediate postoperative period or at least 4 weeks postoperatively, within 14 days prior to registration; if the \within 96-hour of surgery\ scan is more than 14 days before registration, the scan needs to be repeated
Evidence of metastatic disease on bone scan or MRI/computed tomography (CT)
Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease
Evidence of central nervous system (CNS) hemorrhage on baseline MRI or computed tomography (CT) scan (except for grade 1 hemorrhage that has been stable for at least 3 months)
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:\r\n* They are > 2 weeks from surgery\r\n* They have recovered from the effects of surgery\r\n* Evaluable or measurable disease following resection of recurrent tumor is mandated for eligibility into the study\r\n* To best assess the extent of residual disease post-operatively, an enhanced CT/MRI should be done no later than 96 hours after surgery or it will need to be done 4-6 weeks post-operatively; if the 96 hour scan is more than 2 weeks from registration, the scan needs to be repeated
A baseline scan should be performed within 14 days prior to registration and on a steroid dosage that has been stable for at least 5 days otherwise a new baseline MR/CT is required; the same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement
Patients must have shown unequivocal evidence for tumor progression by MRI (or CT for patients who cannot tolerate MRI) in comparison to a prior scan; the same type of scan, i.e., MRI (or CT for patients who cannot undergo MRI) must be used throughout the period of protocol treatment for tumor measurement
Residual disease of recurrent glioblastoma is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, a post-operative MRI scan must be performed prior to registration and is recommended to be within 96 hours post-surgery (although 24-48 hours would be optimum). Note: Patients who did have surgery with a post-operative contrast-enhanced scan falling outside the 5-week window prior to registration, must have a repeat MRI scan within 14 days prior to registration.
Implanted metal or metal devices that make a MRI scan prohibitive, history of claustrophobia or other condition that would make a MRI scan prohibitive
MRI (contrast is not required but strongly recommended) of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement; an MRI is required as it is superior to a CT scan in delineating the spinal cord as well as identifying an epidural or paraspinal soft tissue component; note: if an MRI was done as a screening imaging study for eligibility, the MRI can be used as the required MRI for treatment planning
At least one tumor lesion measurable by CT or MRI scan (according to RECIST v1.1)
Inability to tolerate po; patients who have a computed tomography (CT) scan with contrast dye within 7 days and/or have a pacemaker will be excluded from having a dual energy x-ray absorptiometry (DEXA) scan only
Have had an abdominal imaging test (CT, MRI, or ultrasound) within the past 7 months
All nodules should be persistent at least after three months follow up with 1 dimension (1d)-CT; a reduction up to 15% of the diameter of the largest target nodule from the previous CT scan is allowed
Measurable tumor by CT or MRI
Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan (99m-Tc-MDP or Na-18F) within 4 weeks of enrollment.
Eligibility of a perfusion CT target lesion must be confirmed by the ACR Core Lab prior to study enrollment and the T0 perfusion CT scan
Any condition including, metallic implants or cardiac pacemakers that makes the candidate ineligible for MR imaging; (MRI research screening form will be completed prior to each MRI scan)
SUB-STUDY III: Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities
Evidence of stroke or mass lesion on CT or MRI scan
Three different adult patient groups will be eligible for inclusion in this study: \r\n* Group 1: Adult patients with compelling evidence of primary brain tumor based on clinical and magnetic resonance imaging (MRI) or computed tomography (CT) imaging characteristics that have not yet received surgery, histological diagnosis, or any tumor-directed therapy; such evidence will include: MRI or CT scan-documented mass lesion within the brain, accompanied by anatomically appropriate neurological signs and symptoms, in the absence of a probable competing diagnosis such as brain abscess or primary intracranial hematoma\r\n* Group 2: Newly diagnosed primary malignant brain tumors (World Health Organization [WHO] grade II-IV glial-based tumors) who have not had a complete surgical resection and by contrast MRI or CT have residual tumor >= 1.0 cm in diameter and will be receiving radiotherapy and/or chemotherapy\r\n* Group 3: Patients with probable or possible recurrent primary brain tumor as determined by standard clinical criteria or MRI or CT imaging; the abnormality must be >= 1.0 cm in diameter by contrast MRI or CT or show changes on non-enhancing MRI sequences (T2 or fluid-attenuated inversion recovery [FLAIR])
Visible lesions by either CT, bone imaging, or MRI consistent with disease
Patients who have started radiographic evaluation and underwent CT scan and/or bone scan prior to registration to the study will be able to participate under a late registration provision, provided that the more modern scans (WB/axial MRI and F-18 NaF PET/CT) can be completed within 8 weeks after CT scan and bone scan
Patients undergoing a planning CT scan in the Department of Radiation Oncology with tumor motion assessment - planning 4-dimensional (4D)-CT ordered by the treating radiation oncologist
imaging modalities (bone scan, MRI or CT) OR
Measurable disease on CT scan
No findings of pancreatic disorder as documented by CT or MRI or EUS
Patients for whom the physician is able to identify suitable implantation sites for the anchored transponders on a recent (within the past 8 weeks) CT scan. This will require acquisition of a CT scan if a suitable one is not already available.