[c09aa8]: / clusters / 9knumclustersv2 / clust_1308.txt

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Unequivocal evidence of progressive disease on contrast-enhanced brain computed tomography (CT) or MRI as defined by Response Assessment in Neuro-Oncology (RANO) criteria, or have documented recurrent glioblastoma on diagnostic biopsy
Baseline chest computed tomography (CT) with or without contrast must be performed within months ( days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease
Contrast-enhanced computed tomography (CT) scans of the neck, chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the neck, chest, abdomen and pelvis; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) .; all measurable lesions must be assessed within days prior to registration; tests to assess non-measurable disease must be performed within days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST .)
Patients must have measurable or non-measurable stage III/locally advanced or metastatic carcinoma of the breast where local therapy with curative intent is not possible; lesions must be evaluated =< weeks prior to study randomization; diagnostic-quality computed tomography (CT) scans with both oral and intravenous (IV) contrast are the expected radiologic method, unless an alternative is approved\r\n* NOTE: Where baseline imaging has already been performed =< weeks prior to study randomization, repeat imaging may not be required
Patients must have no evidence of extrapelvic disease; complete workup staging should be performed prior to initiation of therapy to rule-out presence of metastatic disease; this should include: computed tomography (CT) scan of the thorax with IV contrast, as well as a CT of the pelvis and abdomen with IV and oral (PO) contrast performed using multi-detector CT and equal or less than mm slice thickness; if the patient is unable to tolerate contrast, then magnetic resonance imaging (MRI) with IV gadolinium should be performed; a chest x-ray should be done first, and if abnormal, then a CT scan of the chest should be done
Any pT-stage based on American Joint Committee on Cancer th edition eligible; study entry will be based on the following diagnostic workup:\r\n* History/physical examination within days prior to step registration\r\n* Negative distant metastatic workup: \r\n** A computed tomography (CT) scan of the abdomen and pelvis (with contrast [CT without contrast is permitted if the patient is not a candidate for contrast, i.e., renal function or allergy]) or magnetic resonance imaging (MRI) of the pelvis within days prior to step registration; (Please note: Lymph nodes will be considered negative (NO)if they are =< . cm short axis);\r\n** Bone scan within days prior to step registration; (please note: a sodium fluoride [NaF] positron emission tomography [PET]/CT is an acceptable substitute and if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT and/or MRI must be obtained to rule out metastasis)
Contrast-enhanced computed tomography (CT) scans of the chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the chest, abdomen and pelvis; imaging of the head and neck is required only if the patient has a head/neck primary; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; if skin lesions are being followed as measurable disease, photograph with a ruler included and physician measurements, must be kept in the patients chart as source documentation; all measurable lesions must be assessed within days prior to registration; tests to assess non-measurable disease must be performed within days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST .)
Stage II-IVB disease (American Joint Committee on Cancer [AJCC], th edition [ed.]) with no evidence of distant metastasis, based upon the following minimum diagnostic workup:\r\n* History/physical examination by a Medical Oncologist or Clinical Oncologist or Radiation Oncologist or Ear, Nose, Throat specialist (ENT), which must include an endoscopic evaluation, a complete list of current medications, and assessment of weight and weight loss in the past months within days prior to registration\r\n* Evaluation of tumor extent with one of the following combinations required within days prior to registration:\r\n** Magnetic resonance imaging (MRI) of the nasopharynx and neck; or computed tomography (CT) of the nasopharynx and neck with =< mm contiguous slices with contrast and bone windows (to evaluate base of skull involvement). \r\n** MRI of the nasopharynx and positron emission tomography (PET)/CT (with contrast) of the neck\r\n*** Note: If a treatment planning CT scan is used, it must be with =< mm contiguous slices with contrast and be read by a radiologist\r\n* To rule out distant metastasis, patients must undergo the following imaging within days prior to registration:\r\n** A CT scan with contrast of the chest and abdomen (required), and the pelvis (optional), or a total body PET/CT scan (non-contrast PET/CT is acceptable)\r\n** A bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan)
No distant metastases, based upon the following minimum diagnostic workup (NOTE: patients with positive para-aortic nodes- completely resected, PET/CT negative are eligible):\r\n* History/physical examination within days prior to study entry\r\n* Contrast-enhanced imaging of the abdomen and pelvis by either CT, magnetic resonance imaging (MRI), or whole body PET-CT (with or without contrast) within days prior to registration (NOTE: whole body PET-CT is preferred) \r\n* Chest x-ray (posterioranterior [PA] and lateral) or chest CT within days prior to study entry (except for those who have had whole body PET-CT)
Patient must have a CT of chest/abdomen with contrast or FDG-PET/CT scan within days prior to step registration; patients must not have evidence of progression per RECIST . or modified RECIST for pleural tumors
Patient must have a CT of chest/abdomen/pelvis with contrast or FDG-PET/CT scan within days prior to step registration; patient must not have evidence of progression per RECIST . or modified RECIST for pleural tumors
Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:\r\n* History/physical examination within days prior to registration including resting heart rate;\r\n* Fludeoxyglucose F (FDG)-positron emission tomography (PET)/computed tomography (CT) scan for staging within days prior to registration\r\n* Magnetic resonance imaging (MRI) scan with contrast of the brain (preferred) or CT scan of the brain with contrast within days prior to registration; \r\n* Forced expiratory volume in one second (FEV) >= . liter or >= % predicted with or without bronchodilator within days prior to registration;\r\n** Patients who meet the criterion above without oxygen (O), but who need acute (started within days prior to registration) supplemental oxygen due to tumor-caused obstruction/hypoxia are eligible, provided the amount of the O needed has been stable
Patient has one or more metastatic tumors evaluable by CT scan with contrast (or MRI, if patient is allergic to CT contrast media) per RECIST .. Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease must be performed within days prior to randomization. Qualifying scans performed as part of standard of care prior to patient signature of the study informed consent will be acceptable as baseline scanning as long as scanning is performed < days prior to randomization.
Prior to chemotherapy +/- or thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following:\r\n* History/physical examination;\r\n* Computed tomography (CT) of the chest and abdomen with contrast (does not have to be done if the patient has had a positron emission tomography (PET)/CT scan prior to initiating chemotherapy or thoracic radiotherapy)\r\n* MRI of the brain with contrast or diagnostic head CT with contrast\r\n* For patients without evidence of extensive-stage SCLC on chest and abdomen CT and brain MRI or head CT, a PET/CT or bone scan is required to confirm limited-stage SCLC
Locally advanced or metastatic disease not amenable to surgery with curative intent with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) . as determined by the investigator based on an assessment of all known disease sites by computerized tomography (CT) scan or magnetic resonance imaging (MRI) of chest/abdomen/pelvis within days before the first dose of cabozantinib. In patients with intravenous (IV) contrast allergy or borderline renal function, CT without IV contrast or F-fluorodeoxyglucose (F-FDG) positron emission tomography (PET) CT may be used as clinically indicated.
Contrast-enhanced CT or MRI within days prior to start of study drug
Patients should have measurable disease by contrast CT or contrast-enhanced MRI.
One of the following combinations of imaging is required within weeks of registration:\r\n* Or a computed tomography (CT) scan of the neck (with contrast) and a positron emission tomography (PET)/CT of neck and chest (with or without contrast)\r\n* Or an magnetic resonance imagining (MRI) of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast)\r\n* Note: A CT scan of the neck and/or a PET/CT performed for the purposes of radiation planning may serve as both staging and planning tools
Subjects who have received iodinated contrast dye must wait hours prior to starting metformin; if a computed tomography (CT) scan with contrast is scheduled after screening and consent, the metformin cannot be taken until after the CT with contrast has been completed and they have waited hours
Unable to receive iv contrast for required CT scans
Subjects who have received iodinated contrast dye must wait hours prior to starting Metformin; if a computed tomography (CT) scan with contrast is scheduled after screening and consent, the metformin cannot be taken until after the CT with contrast has been completed and they have waited hours
Patients must have had radiographic evidence of tumor progression by brain MRI or computed tomography (CT) scan with contrast
Patients will undergo CT imaging of the chest, abdomen, and pelvis to evaluate lung and liver metastases within days of registration; for patients who cannot tolerate CT contrast or have hepatic steatosis that reduces the sensitivity of CT, MRI of the liver will be performed
Surgically resectable (TN, TN, Tany with node positivity, M), as determined by endoscopic ultrasound (EUS) and the following minimum diagnostic work-up:\r\n* Whole-body PET/computed tomography (CT) (PET/CT of skull base to mid-thigh is acceptable)\r\n* EUS =< days prior to registration\r\n* NOTE: Patients may have regional adenopathy including para-esophageal, gastric, gastrohepatic and celiac nodes; if celiac adenopathy is present, it must be < cm\r\n* NOTE: If patient unable to have PET/CT then CT chest/abdomen/pelvis with contrast (preferred) or MRI chest/abdomen/pelvis with contrast
Clinical stage =< Ta based on digital rectal exam and/or =< Ta based on magnetic resonance imaging (MRI) (if done); N-Nx; M-Mx (American Joint Committee on Cancer [AJCC] th edition)\r\n* T-stage and N-stage will be determined by physical exam including a digital rectal exam and available imaging studies (computed tomography [CT], and/or MRI of the pelvis); for MRI, extracapsular extension is permitted; to distinguish blood from tumor the ideal study would be to acquire T, T noncontrast and T dynamic contrast enhanced sequence, although this is not required\r\n* M-stage determined by physical exam, CT of abdomen and pelvis with contrast, and bone scan
All patients must be staged with a physical exam, computed tomography (CT) of the chest and contrast-enhanced helical thin-cut abdominal CT; unresectability is defined by CT criteria: \r\n* Evidence of tumor extension to the celiac axis or superior mesenteric (SM) artery, or \r\n* Evidence on either CT or angiogram of occlusion of the SM vein or SM/portal vein confluence
Clinically negative lymph nodes as established by abdominal-pelvic computed tomography (CT), no more than days prior to registration; CT only for clinical classification of > T (with contrast if renal function is acceptable; a non-contrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection; patients with lymph nodes equivocal or questionable by imaging are eligible if those nodes are < cm in short axis diameter
Within days of registration: patients must have fludeoxyglucose F (FDG)-positron emission tomography (PET)-CT scan (or CT chest/abdomen/pelvis with IV contrast), and magnetic resonance imaging (MRI) brain with IV contrast (preferred) or CT scan of the brain with contrast; non-contrast MRI scans of the chest/abdomen/pelvis or brain are permitted for workup if patient has allergy to CT contrast or renal insufficiency
Ability to have CT and/or MRI imaging with or without contrast and must be performed within days prior to registration
Inability to have contrast CT or MRI to help define tumor volume for radiation planning
A diagnostic contrast-enhanced magnetic resonance imaging (MRI) of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy; the postoperative scan must be performed within days prior to registration; (contrast enhanced brain computed tomography [CT] is allowed if MRI is contraindicated)
History of severe reaction to contrast-enhanced computed tomography (CT) scan
Cranial magnetic resonance imaging (MRI) or contrast computed tomography (CT) must have been performed within 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 hours of resection is preferred but not required; if the surgical procedure was a biopsy only, a head CT within hours of the biopsy is acceptable; patients without measurable or assessable disease are eligible
Baseline imaging in the form of CT chest, abdomen, pelvis with oral and intravenous contrast within days of study entry; for patients with a contrast allergy, choice of alternative body imaging will be at the discretion of the investigator or his designee; magnetic resonance imaging (MRI) of the brain is only needed if clinically indicated
Contraindication to both CT and MRI contrast agents
No distant metastases, based upon the following minimum diagnostic workup:\r\n* History and physical exam including a detailed description of the location, size and stage of the sarcoma, within weeks prior to study entry\r\n* CT or magnetic resonance imaging (MRI) with contrast of the abdomen and pelvis within weeks prior to study entry; the maximal dimension of the primary tumor will be measured in CT and MRI images; and\r\n* CT scan of the chest within weeks prior to study entry
Allergy to acyclovir or inability to receive contrast for CT and MRI scans
Post-operative imaging (thoracic and whole abdominal CT with contrast medium or MRI) demonstrating no evidence of disease within weeks from randomization
Cranial MRI or contrast CT performed days prior to study entry. Subjects without measurable or assessable disease are eligible.
Must have pathologically-proven adenocarcinoma of the stomach or gastroesophageal (GE)-junction, stage M, as established by both imaging and surgical pathologic staging.\r\n* Imaging: Clinical stage of M will be established by either computed tomography (CT) (chest with contrast and abdomen/pelvis with and without contrast), or CT/positron emission tomography (PET) (skull base to mid-thigh). This is standard post-surgery imaging.\r\n*Surgery: Surgical pathologic staging must be M.
Pre-operative scans including MRI/computed tomography (CT) neck and, CT chest with contrast; if contrast is contraindicated, staging positron emission tomography (PET) or PET-CT is acceptable although high quality/diagnostic cross-sectional imaging of the head and neck area is recommended
Diagnostic quality CT or MRI of neck, with contrast, within days prior to registration; a -F-FDG-PET/CT of the neck only is acceptable as a substitute if the CT is of diagnostic quality and with IV contrast.
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]): cT- =< cm from the anal verge, any N\r\n* Bulky: any cT or evidence that the tumor is adjacent to (defined as within mm of) the mesorectal fascia on MRI or ERUS/pelvic CT (with IV contrast) scan\r\n* High risk for metastatic disease with or more regional lymph nodes (cN); clinical nodal or \cN\ status for eligibility includes the total number of nodes (N = or more) in the mesorectal and superior rectal stations measuring >= . cm in any axis on cross sectional or endoscopic imaging; Note: nodes must measure . 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 T and/or N disease
Definitive clinical or radiologic evidence of metastatic disease; required imaging studies must have been performed within days prior to randomization; Note: Distant clinical staging to exclude patients with overt metastatic disease is determined by:\r\n* Chest: CT scan (preferred); chest x-ray posterioranterior (PA) and lateral (acceptable); or positron emission tomography (PET) scan (acceptable)\r\n* Abdomen: CT scan with IV contrast (preferred); or MRI (acceptable)\r\n* Pelvis: MRI (preferred) or CT scan with IV contrast (acceptable)\r\n** (It is recommended that the same imaging tests that are performed before randomization be used at follow-up time points; Note: CT scans of the abdomen and pelvis must be performed with IV contrast)
Patients must have stage III-IVB head and neck squamous cell carcinoma (HNSCC) (American Joint Committee on Cancer [AJCC] seventh [th] edition) based on the following minimum diagnostic workup within days prior to step registration: \r\n* General history and physical examination by a radiation oncologist, medical oncologist, and/or ear, nose and throat (ENT) or head & neck surgeon\r\n* For larynx, hypopharynx, and base of tongue primaries, a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) is required, unless the patient cannot tolerate or refuses\r\n* Imaging of the head and neck with a neck CT or magnetic resonance imaging (MRI) (with contrast, unless contraindicated) or PET/CT (with contrast, unless contraindicated)\r\n* Chest imaging: chest CT with and without contrast (unless contraindicated) or PET/CT
Pathologic stage III or IV HNSCC, including no distant metastases, based on the following minimum diagnostic workup:\r\n* General history/physical examination by a radiation oncologist and/or medical oncologist within days prior to registration\r\n* Examination by an ear nose and throat (ENT) or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure), if appropriate, is recommended but not required; intra-operative examination is acceptable documentation\r\n* Pre-op Imaging of the head and neck: a neck computerized tomography (CT) (with contrast) or CT/positron emission tomography (PET) (with contrast) and/or an magnetic resonance imaging (MRI) of the neck (T with gadolinium and T) within days prior to surgery; note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in Digital Imaging and Communications in Medicine (DICOM) format via transfer of images and data (TRIAD); the report is to be uploaded into Rave\r\n* Chest imaging with either a CT scan (with or without contrast) or CT/PET (with or without contrast) that includes the chest within days prior to registration; Note: if the CT/PET with or without contrast is done within days prior to surgery, it fulfills the chest imaging requirement
Pathologic stage III or IV HNSCC, including no distant metastases, based upon the following minimum diagnostic workup:\r\n* General history and physical examination by a radiation oncologist and/or medical oncologist within days prior to registration;\r\n* Examination by an ear nose throat (ENT) or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror and/or fiber optic and/or direct procedure), if appropriate, is recommended but not required; intra-operative examination is acceptable documentation\r\n* Pre-operative (op) Imaging of the head and neck: A neck computed tomography (CT) (with contrast) or CT/positron emission tomography (PET) (with contrast) and/or an magnetic resonance imaging (MRI) of the neck (T with gadolinium and T) within days prior to surgery; Note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in Digital Imaging and Communications in Medicine (DICOM) format via TRIAD; the report is to be uploaded into Rave\r\n* Chest CT scan (with or without contrast) or CT/PET that includes the chest (with or without contrast) either within days prior to surgery or within days prior to registration; Note: if the CT/PET with or without contrast is done within days prior to surgery, it fulfills the chest imaging requirement
Clinical stage T-T, N-Nb or T, N-Nb (American Joint Committee on Cancer [AJCC], th edition [ed.]) including no distant metastases based on the following diagnostic workup:\r\n* General history and physical examination within days prior to registration\r\n* Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within days prior to registration\r\n* One of the following combinations of imaging is required within days prior to registration:\r\n** A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast)\r\n** Or a magnetic resonance imaging (MRI) of the neck (with contrast) and a chest CT scan (with or without contrast)\r\n** Or a CT scan of neck (with contrast) and a PET/CT of neck and chest (with or without contrast)\r\n** Or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast)\r\n*** Note: a CT scan of neck and/or a PET/CT performed for the purpose of radiation planning may serve as both staging and planning tools
PHASE II: Patients must be able to tolerate CT, MRI or PET imaging including contrast agents
Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:\r\n* History/physical examination, including documentation of height, weight, body surface area [BSA], and vital signs, within days prior to registration\r\n* Computed tomography (CT) with IV contrast or magnetic resonance imaging (MRI) imaging (if CT scan with contrast is medically contraindicated) of the lung and upper abdomen through the adrenal glands, required within days prior to registration (recommended within days prior to registration\r\n* MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within days prior to registration; note: the use of intravenous contrast is required for the MRI or CT; an MRI without contrast is only permitted if the patient has a contrast allergy\r\n* Whole-body fludeoxyglucose F (FDG)-positron emission tomography (PET)/CT required within days prior to registration (recommended within days prior to registration; note: patients do not need to have a separate CT of the chest and upper abdomen with contrast if PET/CT imaging includes a high quality CT with contrast
CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within weeks prior to registration
The following minimum diagnostic workup is required:\r\n* History/physical examination within weeks prior to registration\r\n* Imaging of neck and brain (computed tomography [CT] scan or magnetic resonance imaging [MRI]) and chest/abdominal imaging (chest x-ray or chest CT scan, or full body positron emission tomography [PET]/CT are acceptable) within weeks prior to registration\r\n* Note: the CT scan of the neck must be done with contrast or if an MRI is done, with gadolinium; therefore, the CT portion of a full body PET/CT has to be a high resolution CT to be acceptable for eligibility\r\n* Abdominal imaging must cover the liver and adrenal glands; therefore, separate imaging is not required if these areas are covered by a chest CT scan\r\n* Electrocardiogram within days prior to registration
Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:\r\n* History/physical examination, including a neurological assessment, within weeks of registration\r\n* Evaluation by a thoracic surgeon within weeks of registration; the patient must be deemed potentially operable and resectable to be eligible for the study\r\n* Whole body fludeoxyglucose F (FDG)-PET (or PET/CT) scan within weeks of registration\r\n* A magnetic resonance imaging (MRI) with contrast of the brain (or CT scan with contrast of brain, if an MRI is medically contraindicated) within weeks of registration\r\n* A CT scan with contrast of the lungs and upper abdomen to complete T and N staging and exclude other ipsilateral or contralateral parenchymal lesions and liver or adrenal metastases within weeks of registration
Evidence of urethral or upper tract transitional cell carcinoma (TCC) within the past years. Subjects with T disease must have no evidence of upper or lower tract disease or a more advanced stage of disease by CT urogram or MRI urogram of the abdomen and pelvis performed within weeks of the first dose of study treatment. If intravenous contrast is contraindicated, retrograde ureteropyelography, or CT or MRI without intravenous contrast may be performed.
Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within days prior to registration\r\n* Low-resolution \localization\ CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol\r\n* If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable
All patients must have disease-free status documented by a complete physical examination and imaging studies within days prior to registration; imaging studies must include a total body positron emission tomography (PET)-computed tomography (CT) scan that is of diagnostic quality (with or without brain) or a CT of the chest, abdomen and pelvis; for patients with melanoma arising from the head and neck, dedicated neck imaging (CT with IV contrast or PET-CT through the region) is required; if the patient has had unknown primary with disease in the axilla, neck imaging is required to assure region is clear of cancer; CT imaging should be done with intravenous contrast if there are no contraindications for it; any other clinically-indicated imaging studies if performed (e.g. bone scan) must show no evidence of disease
Patient must have no evidence of disease on post-operative imaging:\r\n* A computed tomography (CT) of the chest must be obtained within weeks prior to randomization with or without contrast\r\n* A CT of the abdomen/pelvis must be obtained within weeks prior to randomization with intravenous (IV) contrast (oral contrast may be added at the radiologists discretion); an magnetic resonance imaging (MRI) of the abdomen/pelvis with gadolinium may be substituted for the CT if the CT with IV contrast is contra-indicated\r\n* An MRI of the brain with and without gadolinium must be done within weeks prior to randomization; a CT of the brain with and without IV contrast is permitted if MRI is contra-indicated (i.e., pacemaker)
Abdominal/pelvic computed tomography (CT) scan with contrast is preferred; abdominal CT alone is acceptable only if insurance restrictions are experienced; chest CT/x-ray (CT of chest preferred) within days of registration on study (or within days prior to day of chemo post-surgery for those patients having started chemotherapy prior to first step registration); patients allergic to intravenous (IV) contrast can have magnetic resonance imaging (MRI) of the abdomen/pelvis instead
Clinical stage T, N- or T-a, N-, M including no distant metastases, based upon the following minimum diagnostic workup:\r\n* General history and physical examination by a radiation oncologist and/or medical oncologist within weeks prior to registration\r\n* Examination by an ear, nose and throat (ENT) or head & neck surgeon, within weeks prior to registration; a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) is recommended but not required\r\n* Chest x-ray (at a minimum) or chest computed tomography (CT) scan (with or without contrast) or CT/positron emission tomography (PET) of chest (with or without contrast) within weeks prior to registration
CT scan with IV contrast (CT scan without contrast acceptable if IV contrast is medically contraindicated) of the lung and upper abdomen through the adrenal glands within days prior to registration (recommended within days prior to registration)
MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within days prior to registration; note: the use of intravenous contrast is required for the MRI or CT (unless medically contra-indicated).
Whole-body FDG-PET/CT within days prior to registration; Note: patients do not need to have a separate CT of chest and upper abdomen with contrast if PET/CT imaging includes a high quality CT chest with contrast.
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.
Radiographic stability should be determined by comparing contrast-enhanced CT or MRI scans at screening to scans obtained by the same method at least weeks earlier
Any subject who cannot be evaluated by either triphasic liver CT or triphasic liver MRI because of allergy or other contraindication to both CT and MRI contrast agents
Contrast enhanced CT of the chest and upper abdomen
MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated)
PRESTUDY REQUIREMENTS: \r\n* History and physical examination, weight, Zubrod performance status (within weeks pre-study entry)\r\n* Evaluation by thoracic cancer clinician (within weeks pre-study entry)\r\n* Pregnancy test, if applicable (serum or urine, within hours prior to treatment start)\r\n* CT (preferably with contrast unless medically contraindicated; both lungs, mediastinum, liver, adrenals)\r\n* PET (using fluorodeoxyglucose [FDG] with visualization of primary tumor and draining lymph node basins in hilar and mediastinal regions)\r\n* Brain and MRI or head CT with contrast\r\n* Pulmonary function tests (PFTs) - include routine spirometry, lung volumes, diffusion capacity\r\n* Signed informed consent
Clinically determined to be clinically staged (American Joint Committee on Cancer [AJCC] th edition [ed.]) T- N M or T any N- M based upon the following minimum diagnostic workup within days prior to registration:\r\n* Colonoscopy\r\n* History/physical examination (including medication history screen for contraindications)\r\n* Contrast-enhanced imaging of the abdomen and pelvis either by computed tomography (CT), magnetic resonance imaging (MRI), or whole body positron emission tomography (PET)-CT (preferred)\r\n* Chest x-ray (or CT) of the chest to exclude distant metastases (except for those who have had whole body PET-CT per above bullet point)\r\n* Transrectal ultrasound (TRUS) or MRI for T staging
Patients with a history of prior intratumoral bleeding must be evaluated with a non-contrast head CT to exclude acute blood prior to start of treatment
Appropriate stage for protocol entry based upon the following minimum diagnostic workup:\r\n* History/physical examination within days prior to registration\r\n* Fludeoxyglucose F (FDG)-positron emission tomography (PET)/computed tomography (CT) scan for staging within days prior to registration\r\n* Magnetic resonance imaging (MRI) scan with contrast of the brain (preferred) or CT scan of the brain with contrast within days prior to registration
CT or MRI of the neck with and without contrast; Note: a CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as planning tools
Patients must have borderline resectable or locally advanced unresectable pancreatic cancer with no metastatic spread as determined by a baseline diagnostic CT scan with intravenous contrast (or MRI). CT should be performed according to a defined pancreas protocol such as triphasic cross-sectional imaging with thin slices. Optimal multi-phase technique including a non-contrast phase plus arterial, pancreatic parenchymal and portal venous phase of contrast enhancement with thin cuts (mm) throughout the abdomen is preferred. Studies must be evaluated by a radiologist and/or surgeon and deemed borderline resectable or locally advanced unresectable as defined per the NCCN Practice Guidelines in Oncology V., as:
A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within days (preferably days) prior to CD.
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 T-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 mm and 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
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
Inability to complete a MRI or CT scan with contrast of the head
Cranial MRI or contrast CT must have been performed within 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 hours of resection is preferred, but not required; patients without measureable or assessable disease are eligible
Appropriate stage for study entry based on the following diagnostic workup:\r\n* History/physical examination within days prior to registration;\r\n* Imaging of the primary tumor by MRI and/or computed tomography (CT) with and without contrast and/or positron emission tomography (PET)/CT within days prior to registration;\r\n* Staging workup evaluated by chest CT and/or PET/CT showing no distant metastasis within days prior to registration
Patients must have borderline resectable pancreatic cancer with no metastatic spread as determined by a baseline diagnostic CT scan with intravenous contrast (or MRI). CT should be performed according to a defined pancreas protocol such as triphasic cross-sectional imaging with thin slices. Optimal multi-phase technique including a non-contrast phase plus arterial, pancreatic parenchymal and portal venous phase of contrast enhancement with thin cuts (mm) throughout the abdomen is preferred. Studies must be evaluated by a radiologist and/or surgeon and deemed borderline resectable as defined below:
Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:\r\n* History/physical examination, including recording of pulse, blood pressure (BP), weight, and body surface area, within days prior to registration\r\n* Whole body fludeoxyglucose-positron emission tomography (FDG-PET)/CT (orbits to mid-thighs) within days prior to registration; PET/CT must be negative for distant metastasis\r\n* CT scan with contrast of the chest and upper abdomen to include liver and adrenals (unless medically contraindicated) within days prior to registration\r\n* Magnetic resonance imaging (MRI) of the brain with contrast (or CT scan with contrast, if MRI medically contraindicated) within days prior to registration
No evidence of metastatic disease as determined by chest computed tomography (CT) scan, and abdominal CT scan (or magnetic resonance imaging [MRI] with gadolinium and/or manganese); all patients must be staged with a physical exam, chest CT, abdominal CT with intravenous contrast (or abdominal MRI with gadolinium and/or manganese)
Imaging features worrisome for malignancy (heterogeneous tumor, presence of calcifications, necrosis, > Hounsfield units on an unenhanced CT scan, and delayed washout of contrast)
Stage clinical T N M or T N M as per American Joint Committee on Cancer (AJCC) Staging system th edition, based on the following criteria:\r\n* Chest computed tomography (CT) with upper abdomen to include the liver and adrenal glands with intravenous (IV) contrast (unless medically contraindicated) within months of registration\r\n* Participants must have measurable disease, defined as >= mm on a diagnostic CT scan with slice thickness of no more than . mm\r\n* Positron emission tomography (PET)/CT scan including neck, chest, abdomen, pelvis within months of study enrollment characterizing the primary tumor and documenting the absence of nodal and distant metastasis\r\n* Brain magnetic resonance imaging (MRI) with gadolinium within months of study enrollment demonstrating the absence of brain metastasis; if an MRI is medically contraindicated or if the patient refuses, a head CT with IV contrast is acceptable
cT or cT
Radiographic evidence of radiation pneumonitis on a computed tomography (CT) scan of the chest with or without contrast
Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) .; contrast-enhanced computed tomography (CT) scans of the neck, chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the chest, abdomen and pelvis; imaging of the head and neck is required only if the patient has a head/neck primary; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; if skin lesions are being followed as measurable disease, photograph with a ruler included and physician measurements, must be kept in the patients chart as source documentation; all measurable lesions must be assessed within days prior to registration; tests to assess non-measurable disease must be performed within days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST .)
Subjects who have received iodinated contrast dye must wait hours prior to starting metformin; if a computed tomography (CT) scan with contrast is scheduled after screening and consent, the metformin cannot be taken until after the CT with contrast has been completed and they have waited hours
Patients must have had a contrast-enhanced computerized tomographic (CT) scan of the chest and abdomen within months of study entry and be willing to have a follow up scan within months of the completion of the retreat
Administered IV x-ray contrast medium ? hours prior to the date of study PET/CT
Administered oral contrast medium ? hours prior to the date of study PET/CT
Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)- (per the institutions upper limit of normal) and computed tomography (CT) scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA- and CT scan or MRI with contrast)
Patient must have perfusion CT target lesion (e.g., >= cm in both the long and short axis, at least one half of the tumor appears enhancing and solid on a contrast-enhanced scan or has an attenuation of >= Hounsfield unit [HU] on the unenhanced CT scan) on a contrast-enhanced conventional CT
Had a prior Ga DOTATATE PET/CT scan and a CT or magnetic resonance imaging (MRI) with or without contrast performed within months before signing the consent, without interval treatment other than a somatostatin analog
Standard of care CT abdomen examination planned with intravenous (IV) contrast.
Patients scheduled and approved for contrast enhanced CT that includes imaging of the abdomen and pelvis following the Department of Radiology standard of care protocol
Patient scheduled for CT that includes the abdomen with a multiphasic contrast enhanced protocol (e.g. triple phase or quadruple phase liver CT)
Contraindication to CT or MRI contrast
IF CT CONTRAST AGENTS ARE TO BE USED:
Inclusion Criteria:\n\n Male or female patients with either:\n\n Newly diagnosed non small cell lung cancer (NSCLC) (Group A) who meet the following\n criteria:\n\n - Previously untreated, histologically or cytologically confirmed stage IIB, IIIA or\n IIIB disease, without evidence of distant metastases\n\n - A measurable primary tumor with at least one diameter > cm or primary tumor\n extending to one or more lymph nodes which cannot be distinctively delineated as\n confirmed by a diagnostic quality chest CT performed within weeks prior to\n initiation of the concurrent CRT.\n\n - Planned to receive concurrent chemoradiotherapy as definitive treatment. The radiation\n dose should not exceed Gy.\n\n - Undergone the following minimum workup to confirm disease staging within weeks prior\n to initiation of the concurrent CRT:\n\n - GBCA-enhanced Brain MRI or contrast enhanced CT if there are signs or symptoms\n suggesting brain metastases within the past months.\n\n - If necessary to confirm stage of disease, an upper abdomen CT scan will be\n performed.\n\n - whole-body FDG PET/CT; OR\n\n - Newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) (Group B) who\n meet the following criteria:\n\n - Previously untreated, histologically or cytologically confirmed (from the primary\n tumor and/or lymph nodes) stage III-IV disease without evidence of distant\n metastases.\n\n - A measurable (i) primary tumor with at least one diameter ? cm and (ii) lymph\n node with at least one diameter ? cm as confirmed by a diagnostic quality neck\n CT performed within weeks prior to initiation of the concurrent CRT.\n\n - Planned to receive concurrent chemoradiotherapy as definitive treatment. The\n radiation dose should not exceed Gy.\n\n - Have undergone the following minimum workup to confirm disease staging within \n weeks prior to initiation of the concurrent CRT:\n\n - Whole-body FDG PET/CT.\n\n - Patients ? years of age.\n\n - Able to comply with lying still during the PET/CT imaging session which may last for\n up to hrs with intermediate breaks.\n\n - ECOG performance status of , or .\n\n - Adequate renal function and adequate hepatic function, as assessed by standard\n laboratory criteria and defined as:\n\n - Serum creatinine ? . times the Upper Limit of Normal (ULN).\n\n - Total bilirubin ? . times the ULN.\n\n - Asparagine aminotransferase (AST) and/or alanineaminotransferase (ALT) ? . times the\n ULN (grade according to the NCI-CTCAE v.).\n\n - Women of child-bearing potential must have a negative blood pregnancy test at\n screening and use an adequate and medically acceptable contraceptive method.\n\n - Willing and able to comply with the protocol requirements.\n\n - Able to provide written informed consent.\n\n Exclusion Criteria:\n\n Exclusion criteria specific to patients with NSCLC (Group A):\n\n - Predominant small cell carcinoma histology.\n\n - Pure bronchioalveolar cell carcinoma histology.\n\n - Treatment planned with chemotherapy other than a platinum-based doublet regimen.\n\n - Malignant pleural or pericardial effusions.\n\n - Any contraindication to perform CT with IV contrast agent.\n\n Exclusion criteria specific to patients with SCCHN (Group B):\n\n - Histology other than squamous cell carcinoma.\n\n - Treatment planned with chemotherapy other than a platinum-based regimen.\n\n - Treatment planned with cetuximab.\n\n - Treatment with induction chemotherapy.\n\n - Any contraindication to CT with IV contrast agent.\n\n - Evidence of distant metastases.\n\n - Patients who, based on the investigator's judgment, have other unstable medical\n conditions that may preclude safe and complete study participation.\n\n - Treatment with any investigational drug, device or biologic agent within days prior\n to administration of [F]-ML-.\n\n - Pregnancy or lactation.
Stage T-bN-, by the American Joint Committee on Cancer (AJCC) th edition, based on the following minimum workup:\r\n* CT chest/abdomen with contrast\r\n* MRI pelvis with contrast\r\n* PET/CT of the whole-body or skull base to mid-thigh
No evidence of metastatic disease on conventional imaging, including a negative bone scan for skeletal metastasis and negative contrast-enhanced CT
Patients who have received any contrast medium (X-ray, MRI, computed tomography [CT] or ultrasound [US]) in the hours prior to the research US exam
Presently planned for restaging using contrast-enhanced computed tomography (CT) scans at baseline and at least every months, as a part of their standard of care assessments
Diagnostic imaging of the abdomen utilizing either CT with contrast, magnetic resonance imaging (MRI), or PET/CT no greater than weeks prior to registration
Undergone a non-contrast chest CT in a time frame that will accommodate experimental imaging (s-DCT) within weeks
Patient is unable to undergo contrast-enhanced CT
Not suitable to undergo CT with an iodinated contrast agent:\r\n* Weight greater than that allowable by the CT table
Patients must have no contra-indications to PET/CT or MRI (patients will NOT be receiving either CT or MRI contrast and thus, those contraindications are not exclusionary)