Children must commence Induction chemotherapy within 28 days of the most recent definitive surgical procedure and within 21 days of the most recent neuro-imaging studies (magnetic resonance imaging [MRI] of brain, performed with and without gadolinium contrast, and MRI of total spine, performed with gadolinium contrast) and lumbar cerebrospinal fluid (CSF) cytological examination; the required eligibility observations must be done within 21 days of the start date of treatment; the date protocol therapy is projected to start must be no later than 7 calendar days after the date of study enrollment
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
A contrast enhancing brain tumor that is any of the following:
Patients must have eligibility confirmed by rapid central imaging review on APEC14B1; standard whole brain magnetic resonance imaging (MRI) with and without contrast (gadolinium) and spine MRI with contrast (gadolinium) must be performed at the following time points:\r\n* Pre-operative to include an MRI of the brain with and without contrast (including post-contrast three-dimensional [3D] T1-weighted image [T1WI] and post-contrast fluid-attenuated inversion recovery [FLAIR])\r\n* Pre-operative spinal MRI with gadolinium; post-operative staging spinal MRI may be obtained if pre-operative imaging is not possible or is suboptimal; pre-operative spine imaging is strongly preferred, due to the potential of post-operative sequelae, which could affect metastasis detection\r\n* Post-operative brain MRI within 72 hours of surgery
GTR must be confirmed on post-operative imaging following the most recent surgery; submission of both pre-operative and post-operative MRIs is required for patients; if a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained; all sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration; imaging subsequent to enrollment must include pre and post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2 fluid attenuated inversion recovery (FLAIR) sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; the post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection; these same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery; computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis
Contraindications to MRI and use of intravenous gadolinium-based contrast agents
Known contraindication to MRI with gadolinium contrast, such as cardiac pacemaker, shrapnel, or ocular foreign body
Patients unable to undergo gadolinium contrast-enhanced magnetic resonance imaging (MRI) or receive IV contrast for any reason (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity, hypersensitivity)
Patients unable to undergo gadolinium contrast-enhanced magnetic resonance imaging (MRI) or receive IV contrast for any reason (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity, hypersensitivity)
Locally advanced HCC as defined by: 1) tissue diagnosis OR 2) alpha-fetoprotein (AFP) > 400 ng/mL with compatible mass on contrast-enhanced imaging OR 3) compatible mass on dual phase computed tomography (CT) or dynamic contrast enhanced magnetic resonance imaging (MRI) demonstrating both arterial hypervascularity and delayed washout
History of anaphylactic allergic reactions attributed to agents used in study (i.e. doxirubicin, epirubicin, MRI contrast agents or iodinated contrast agents)
Have a history of allergy to iodinated contrast media
Patients must have a gadolinium contrast-enhanced three-dimensional (3D), spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) magnetic resonance imaging (MRI) scan and an axial T2/fluid attenuation inversion recovery (FLAIR) sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; sites may contact the Imaging Co-Chairs for further information or assistance if needed\r\n* This MRI must be obtained within 56 days of Step 1 registration.\r\n* Note: the MRI study is mandatory irrespective of randomization to the experimental or control arm of this study
Hypersensitivity to IV contrast; not suitable for pre-medication
ARM I&II: Patients must have gadolinium magnetic resonance imaging (MRI) or contrast computed tomography (CT) with contrast within 28 days prior to starting treatment
A contrast-enhanced MRI must be obtained within 7 days of the first dose of study treatment
Subjects who have a contraindication for 3T MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
Subjects with an allergy to contrast agents may be enrolled at the treating physician’s discretion with appropriate pre-treatment and symptom management
A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging
Patients with contraindications to intravenous (IV) contrast administration are still eligible for this study if the tumor can be delineated clearly without IV contrast (at the discretion of the treating radiation oncologist) but will not participate in the functional imaging studies
Subjects who have a contraindication for 3 tesla (3T) MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
Contrast-enhanced CT or MRI within 14 days prior to start of study drug
Patients should have measurable disease by contrast CT or contrast-enhanced MRI.
Has an allergy or hypersensitivity to chili peppers, capsaicin, or radiographic contrast agents.
Diabetes\r\n* In addition, patients with glomerular filtration rate (GFR) < 15 ml/min/1.73 m^2 or who are on dialysis will not have dynamic contrast-enhanced (DCE)-MRI scan; these patients will have conventional anatomical MRI without contrast and diffusion weighted (DW)-MRI
Inability to undergo MRI secondary to: a) metal b) claustrophobia c) gadolinium contrast allergy
Patients must have demonstrated evidence of increasing contrast enhancement on MR or computed tomography (CT) imaging while on stable or increasing dose of steroid
Subjects must not have a tumor > 2 cm as measured on prone contrast-enhanced breast MRI
Contraindication to angiography/embolization including:\r\n* Patients cannot receive contrast:\r\n** Severe allergic reaction to contrast despite premedication\r\n** Poor renal function not on dialysis\r\n* Other, based on judgment of the investigator
Subjects who have received iodinated contrast dye must wait 12 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 12 hours
Unable to receive iv contrast for required CT scans
Patients not eligible to obtain MRI with and without contrast
Subjects who have received iodinated contrast dye must wait 12 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 12 hours
Multifocal disease (> 1 lobe of involvement) of discontiguous contrast enhancing disease as seen on conventional MRI
Contraindications to gadolinium contrast-enhanced MRI (e.g., non-compatible pacemaker, estimated glomerular filtration rate [eGFR] < 30, gadolinium allergy)
Allergy to X ray contrast agents.
Severe allergy to contrast agent.
Prior allergic reaction to gadolinium-based contrast agents (if receiving contrast for MRI)
Patients who cannot obtain a contrast-enhanced MRI or CT myelogram due to allergy, renal failure or other medical contraindication
Contraindication to MRI scans or intravenous contrast
Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds)
Contraindication for contrast-enhanced MRI as defined by the standard operating procedures of the Department of Radiology at University of Texas (UT) Southwestern; briefly, these include medically unstable; cardiac pacemaker; intracranial clips, metal implants; metal in the eyes; pregnant or nursing; claustrophobia; and impairment of the renal function with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2; patients with one or more of these contraindications but eligible to undergo contrast-enhanced CT can participate in this study and will not receive an MRI
MRI MONITORING SUB-STUDY: Previously had an allergic response to MR contrast agents (gadolinium)
Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds) or severe anxiety/claustrophobia related to MR imaging despite medications to relieve anxiety/claustrophobia (first 10 patients only; however, an investigator can still choose to enroll patients onto the trial who have these contra- indications to MRI; these patients will not receive the two research MRIs at the Wright Center)
Contrast-enhancing tumor which crosses the midline
Contraindication to both contrast enhanced magnetic resonance imaging (MRI) and contrast enhanced computed tomography (CT) (i.e. unable to undergo follow-up imaging or SBRT treatment planning)
Ability to have CT and/or MRI imaging with or without contrast and must be performed within 120 days prior to registration
Inability to have contrast CT or MRI to help define tumor volume for radiation planning
Exclusion criteria (MRI specific):\r\n* Patients who are ineligible to undergo an MRI scan for reasons such as claustrophobia or the presence of implanted devices or metallic foreign bodies that are not magnetic resonance (MR) compatible; patients with a known history of allergic reaction to gadolinium contrast agents; patients with a history of a glomerular filtration rate (GFR) of less than 60 or acute renal disease
Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans.
Contraindication to both CT and MRI contrast agents
More than four metastases by baseline post-contrast MRI
Allergy to acyclovir or inability to receive contrast for CT and MRI scans
Targeted (most painful) tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
NOT visible by non-contrast MRI, OR
Post-operative imaging (thoracic and whole abdominal CT with contrast medium or MRI) demonstrating no evidence of disease within 4 weeks from randomization
Cranial MRI or contrast CT performed 14 days prior to study entry. Subjects without measurable or assessable disease are eligible.
Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans.
Multifocal disease (> 1 lobe of involvement) of discontiguous, contrast enhancing disease as seen on conventional MRI.
Is unable (due to existent medical condition) or unwilling to have a contrast enhanced MRI of brain
Patients with known allergy to intravenous iodinated contrast agents
Patients with a contraindication to contrast-enhanced MRI
Presence of a medical device (pacemaker, stent) or allergy that precludes contrast enhanced MRI
Cranial MRI (with and without gadolinium) must be done pre-operatively; post-operatively, cranial MRI (with and without gadolinium) must be done, preferably within 48 hours of surgery; entire spinal MRI must be obtained either pre-operatively (with gadolinium) or post-operatively (at least 10 days following surgery) prior to study enrollment (with and without gadolinium); patients with MRI evidence of spinal disease are eligible for this study
Allergy to or intolerance to iodinated contrast media despite standard of care pre-medication
Able to undergo MRI evaluation with gadolinium contrast
Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible prosthesis)
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 30 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 45 days prior to registration (recommended within 30 days prior to registration\r\n* MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 45 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 18 (FDG)-positron emission tomography (PET)/CT required within 45 days prior to registration (recommended within 30 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
Patients must have:\r\n* Pre-operative cranial magnetic resonance imaging (MRI) (recommended with gadolinium) or pre-operative computed tomography (CT) (recommended with contrast)\r\n* Post-operative cranial MRI with and without gadolinium within 72 hours of surgery\r\n* Spinal MRI pre-op with and without gadolinium or post-op with and without gadolinium preferably within 72 hours of surgery
No systemic steroid use within 2 weeks prior to initiation of experimental therapy; limited doses of systemic steroids to prevent intravenous (IV) contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed
Evidence of urethral or upper tract transitional cell carcinoma (TCC) within the past 2 years. Subjects with T1 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 8 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.
Patient must have no evidence of disease on post-operative imaging:\r\n* A computed tomography (CT) of the chest must be obtained within 4 weeks prior to randomization with or without contrast\r\n* A CT of the abdomen/pelvis must be obtained within 4 weeks prior to randomization with intravenous (IV) contrast (oral contrast may be added at the radiologist’s 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 8 weeks prior to randomization; a CT of the brain with and without IV contrast is permitted if MRI is contra-indicated (i.e., pacemaker)
Contraindications to administration of gadolinium-based MRI contrast agent (e.g. Magnevist), such as chronic, severe kidney disease, acute kidney injury, history of Sickle Cell Disease, history of anemia, or intolerance/allergy to the contrast agent
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 60 days prior to registration (recommended within 30 days prior to registration)
MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 60 days prior to registration; note: the use of intravenous contrast is required for the MRI or CT (unless medically contra-indicated).
Is unable (due to existent medical condition) or unwilling to have a contrast enhanced MRI of brain
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
Contraindications to MRI 2.1. Claustrophobia 2.2. Implanted ferromagnetic materials or foreign objects 2.3. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) 2.4. Known contraindication to utilization of MRI contrast agent
Oral or intravenous iodinated contrast administration =< 6 weeks prior to registration
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 4 weeks pre-study entry)\r\n* Evaluation by thoracic cancer clinician (within 8 weeks pre-study entry)\r\n* Pregnancy test, if applicable (serum or urine, within 72 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
Patients must have measurable disease, defined as at least one meningioma >= 1.0 ml (on volumetric analysis performed by the Tumor Imaging Metric Core at Dana Farber [DF]/Harvard Cancer Center [HCC]) that can be accurately measured by contrast-enhanced cranial MRI scan, performed within 28 days of study registration
Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy or compromised renal function (creatinine > 2.0)
Inability to get brain MRI +/- contrast
The primary tumor must be resectable, defined as no involvement (abutment or encasement) of the major arteries (celiac, common hepatic, superior mesenteric) and interface between tumor and vessel (portal, superior mesenteric veins) wall to be less than 180 degrees of the circumference of the vessel wall; this should be confirmed by imaging of the abdomen, either by a contrast-enhanced computed tomography (CT) scan, or a contrast-enhanced magnetic resonance imaging (MRI) scan; PET scans will not be adequate alternatives; for each patient, the resectability must be reviewed by one of the study surgeons
Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality
Patients who have a history of allergy to iodides or iodinated contrast agents
Known contraindication to MRI with gadolinium contrast, such as cardiac pacemaker, shrapnel, or ocular foreign body
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 (3mm) 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 V2.2012, as:
Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.
Inability to tolerate periodic MRI scans or gadolinium contrast
To document the degree of residual tumor, the following must be obtained:\r\n* All patients must have a brain MRI with and without contrast (gadolinium) within 1 week prior to study enrollment; for patients on steroids, baseline MRI scans must be performed after at least 1 week at a stable or decreasing dose of steroids\r\n* All patients with a history of spinal or leptomeningeal disease, and those patients with symptoms suspicious of spinal disease, must have a spine MRI with and without contrast (gadolinium) performed within 2 weeks prior to study enrollment
Contraindication to magnetic resonance (MR) imaging such as implanted metal devices or foreign bodies, severe claustrophobia AND patients unable to receive gadolinium contrast agents
Progressive disease on contrast-enhanced brain computed tomography (CT) or magnetic resonance imaging (MRI) as defined by MacDonald Criteria, or have documented recurrent glioblastoma on diagnostic biopsy; patients who have been previously treated with bevacizumab therapy that have T2-weighted or fluid attenuation inversion recovery (FLAIR) MRI sequences considered to be progressive disease by the study investigator but have no contrast-enhancing areas of recurrent disease are eligible for Arm C; Arm A patients may continue treatment in the post-operative period even if there is no residual contrast-enhancing tumor after surgery
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 (3mm) throughout the abdomen is preferred. Studies must be evaluated by a radiologist and/or surgeon and deemed borderline resectable as defined below:
Result from a post-operative contrast-enhanced brain MRI within 72 hours after surgery or biopsy.
Evidence of recent hemorrhage on post-operative contrast enhanced brain MRI (except hemosiderin, resolving hemorrhage changes related to surgery, presence of punctuate hemorrhage in tumor).
Measurable contrast-enhancing disease by MRI of brain and or spine (with gadolinium contrast).
Targeted tumor is clearly visible by non-contrast MRI
Known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease
Targeted tumors:\r\n* NOT visible by non-contrast MRI,\r\nOR\r\n* NOT accessible to ExAblate device
Subjects who have received iodinated contrast dye less than 48 hours prior to screening meet a temporary exclusion criteria to receive metformin; these patients cannot start investigational metformin until 48 hours have elapsed from contrast administration; subjects who are scheduled for iodinated contrast dye administration within 48 hours of definitive surgery are excluded
Known contraindication to intravenous gadolinium contrast administration (e.g., renal impairment, known allergy); standard institutional policies on gadolinium and renal function will be followed
Patients must have abnormal enhancement on contrast enhanced MRI of the brain; they must be patients for whom bevacizumab is indicated and appropriate, as drug will be charged to insurance
People who progress with only nonenhancing tumor on MRI are ineligible; patients must have some component of abnormal enhancement on contrast enhanced MRI of the brain; combinations of nonenhancing and enhancing tumor are eligible
Patient must have no contraindication for CT with iodinated contrast
Contrast-enhancing tumor that is any of the following:
Imaging features worrisome for malignancy (heterogeneous tumor, presence of calcifications, necrosis, > 10 Hounsfield units on an unenhanced CT scan, and delayed washout of contrast)
At least one measurable lesion defined as lesion(s) that can be accurately measured in at least two dimensions and is ? 10 mm in each dimension by Gadolinium (Gd)-MRI, irrespective of slice thickness/reconstruction interval, for CNS lesions and CT or MRI (with or without contrast) for non-CNS lesions. All patients with CNS lesions must have a brain MRI with and without gadolinium and a spine MRI with gadolinium within 2 weeks prior to first dose of study treatment.
Contra-indications to receiving gadolinium contrast
Ability to receive intravenous contrast for the purpose of imaging
Measurable disease demonstrating intratumoral arterial enhancement by contrast enhanced computerized tomography (CT), with use of multislice scanners, or contrast enhanced dynamic magnetic resonance imaging (MRI), with at least 1 tumor lesion that meets the following criteria: located in the liver; can be accurately measured in at least 1 dimension; well delineated area of viable, hypervascular (contrast enhancement in the arterial phase) tumor that is >2 centimeter (cm) in the axial plane; suitable for repeat measurement; OR not previously treated with locoregional or systemic treatment unless the lesion shows a well-delineated area of viable (contrast enhancement in the arterial phase) tumor that is >2 cm in the axial plane. (If the lesion is poorly demarcated or exhibits atypical enhancement as a result of the previous intervention, then it cannot be selected as a target lesion)
History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents, or other contraindication to gadolinium contrast and other known contraindication to MRI;
If the conventional MR findings are not seen, the following dynamic susceptibility-contrast (DSC) MR characteristics may be used to meet eligibility for this study:\r\n* DSC MR\r\n** The cut-offs below will be based on gradient echo type echo planar imaging (GRE- EPI) DSC perfusion images, acquired without using a gadolinium pre-load:\r\n*** Relative cerebral blood volume (rCBV) < 1.5 in the enhancing-lesion relative to normal-appearing white matter (NAWM)\r\n*** Percentage of signal recovery (PSR) >= 76%, where PSR is determined by comparing the lower signal intensity during passage of the contrast bolus with the post-contrast signal intensity on the signal intensity-time curve
Post-operative MRI imaging with contrast is mandatory obtained for radiation therapy planning and must be 30 days prior to the start of radiation therapy; enrolling sites are not mandated although highly encouraged to obtain thin-slice (< 1.5 mm) 3 dimensional (D) axial T2/FLAIR and T1 pre and post contrast sequences for planning purposes
Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
Targeted (most painful) tumor NOT visible by non-contrast MRI,
Confirmation of tumor recurrence or progression on contrast MRI (with and without gadolinium contrast) as determined by RANO criteria within 14 days prior to registration for patients who did not have recent resection of their glioblastoma or only had a stereotactic biopsy.
> 1 cm diameter of blood seen on contrast MRI (with and without gadolinium contrast)
Subjects who have received iodinated contrast dye; metformin treatment can be started the day after subjects complete iodinated contrast treatment; if a computed tomography (CT) scan with contrast is scheduled after screening and consent, the metformin treatment should be stopped the day before iodinated contrast administration; metformin can be resumed on the day after last iodinated contrast was administered to the subject
Patient has inability to tolerate 4D CT scan (for example; contrast intravenous [IV] allergy, claustrophobia, renal disease)
Absolute contraindication to intravenous iodinated contrast (history [Hx] of significant previous contrast reaction, not mitigated by appropriate pre-medication)
Patients allergic to contrast dye used in MRIs or CT scans or who cannot be premedicated for the use of contrast dye
Patients must have a post-gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2/FLAIR sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; this MRI must be obtained =< 21 days prior to step 1 registration
Contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
Subjects who have received iodinated contrast dye must wait 12 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 12 hours
Patients with 1-10 measurable brain metastases on a diagnostic-quality contrast-enhanced MRI obtained within 30 days prior to registration
Allergy or prior reaction to the fluorescent contrast agent proflavine
Allergy or prior reaction to the fluorescent contrast agent proflavine
EXCLUSION - PATIENT: History of adverse or allergic-like reaction to gadolinium MRI intravenous contrast, rendering the participant unable to safely receive intravenous contrast based on institutional clinical protocol
Contraindication to gadolinium (Gd) contrast agents
Patients with contraindication to the intravenous use of iodinated contrast agent (i.e. allergy to iodinated contrast or severely impaired renal function with a creatinine level >= 1.3)
Previous reactions to iodinated contrast media
Patient must be able to undergo breast MRI with contrast enhancement; patients unable to undergo breast MRI with contrast enhancement for any reason are ineligible\r\n* No history of untreatable claustrophobia\r\n* No presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication\r\n* No history of sickle cell disease\r\n* No contraindication to intravenous contrast administration\r\n* No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance\r\n* No known or suspected renal impairment; requirements for glomerular filtration rate (GFR) prior to MRI as determined by local site standard practice\r\n* Weight less than or equal to the MRI table limit\r\n* No women who have had prior contrast enhanced mammography (contrast enhanced spectral mammography [CESM] or contrast enhanced digital mammography [CEDM])\r\n* No women who have breast prosthetic implants (silicone or saline)
Women who have a contraindication to the intravenous use of iodinated contrast agent (i.e., allergy to iodinated contrast or severely impaired renal function with a creatinine level >= 1.3)
Participants planning to undergo elective radiologic studies involving intravascular administration of iodinated contrast materials
Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections\r\n* Ability to withstand 22-gauge intravenous (IV) placement\r\n* No history of untreatable claustrophobia\r\n* No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies\r\n* No contraindication to intravenous contrast administration\r\n** Adequate organ function, including adequate renal function defined as estimated glomerular filtration rate (eGFR) >= 40 mL/min/1.73 m^2 as calculated per institution standard of care, and meeting local site requirements for intravenous administration of gadolinium-based MRI contrast agents\r\n* No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance\r\n* Weight compatible with limits imposed by the MRI scanner table
Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five physical half-lives, or any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.
Has contraindication to MRI contrast
Patients in which gadolinium contrast is contra-indicated
Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR < 30)
Women who have a contraindication to the intravenous use of iodinated contrast agent (i.e., allergy to iodinated contrast or severely impaired renal function with a creatinine level > 1.3 or estimated glomerular filtration rate [eGFR] >= 45)
Known allergic reaction to gadolinium; patient may be eligible if the referring physician determines that the MRI is medically necessary and if the patient is willing to undergo pre-medication for contrast allergy
Patient must not have contraindication to iodinated contrast
Patient must have perfusion CT target lesion (e.g., >= 1 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 >= 10 Hounsfield unit [HU] on the unenhanced CT scan) on a contrast-enhanced conventional CT
Subjects who have a contraindication for 3 tesla (T) MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
Participants who have documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure
History of allergic reactions to gadolinium-based MRI contrast agent
No intravenous (IV) or oral contrast medium within the week prior to enrollment
History of hypersensitivity to iodinated contrast agent
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
Subjects who have a contraindication for 3Tesla (3T) MRI, or have an allergy to gadolinium containing contrast material
Patients with a contraindication to gadolinium based contrast agents, including allergy or impaired renal function (per UW health guidelines)
Women with gadolinium contrast allergy
Subject has an allergy against iodinated contrast agents and cannot be premedicated
For patients with known history of allergic reaction to MR contrast material or abnormal kidney function (glomerular filtration rate [GFR] < 30 mL/min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed in these patients
Allergy to gadolinium containing contrast media
History of anaphylactoid reaction to iodinated contrast material
History of iodinated contrast allergy
Any other contraindication to CT with iodinated contrast, as CT with contrast will be used in the study
Patient who require reduced intravenous contrast dose based on the Department of Radiology contrast policy
Patients with a known allergy against any component of the contrast enhancing MR agent will not receive MR contrast agents; (exclusion criterion only for contrast enhanced MRI)
Known allergy to FDG or gadolinium based contrast agents
Patients with a known allergy or hypersensitivity to MRI contrast agents including gadolinium
Contraindication to CT or MRI contrast
Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy or those with inadequate renal function
Patients with a contraindication to contrast-enhanced MRI
Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis)
Patients with a known allergy to MR contrast agents
Known or suspected diagnosis of intracranial glioma with substantial non-enhancing regions as assessed by contrast enhanced MRI; for the purposes of this study, gliomas with substantial non-enhancing regions are defined as having contrast-enhancing volumes of less than 80% of the total estimated tumor volume; gliomas that do not have any contrast-enhancing regions are eligible for this study
Subject is not a candidate for multiparametric MRI with contrast; some reasons may include (but are not limited to): renal insufficiency, foreign body or pacemakers
Previously known allergies against MRI contrast agents (exclusion criterion only for contrast enhanced MRI)
Participants with any contraindications to gadolinium-based contrast agents
IF CT CONTRAST AGENTS ARE TO BE USED:
Previous intravenous (IV) contrast allergy
Hypersensitivity to the contrast agent 'Definity'
Patients who are allergic to gadolinium based contrast agent
Any contraindication to gadolinium intravenous contrast as per standard Department of Radiology contrast guidelines
Patient with allergy to contrast agent
Any contraindication to gadolinium intravenous contrast as per standard Department of Radiology contrast guidelines
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, need monitored anesthesia for scanning, or have an allergy to Gd contrast material
History of moderate or severe reaction to contrast agent injection
Any patient with a history of a severe reaction (Common Toxicity Criteria [CTC] version [v.]4 grade >= 2) to gadolinium or other contrast agents
have been allergic to contrast agents;
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium (Gd) contrast material
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium (Gd) contrast material
Renal function impairment preventing administration of MRI contrast
Patients who have received any contrast medium (X-ray, MRI, computed tomography [CT] or ultrasound [US]) in the 24 hours prior to the research US exam
Subjects with a contraindication to receiving gadolinium containing contrast for the MRI
Renal function impairment preventing administration of MRI contrast
Patients with allergy to iodinated contrast
If agreeing to MRI contrast, participant must not have had a prior allergic reaction to gadolinium-based contrast agents
Subjects who have contraindication to contrast enhanced MRI examination; contraindications to MRI examinations include:\r\n* Medically unstable\r\n** Heart failure\r\n** Unstable angina\r\n** Child bearing\r\n** Lactating\r\n* Any contraindication per MRI screening form \r\n** Implants contraindicated at 3T, pacemakers\r\n** Poorly controlled diabetes\r\n** Body weight greater than 300 pounds\r\n** Claustrophobic\r\n* Since each patient is receiving a gadolinium based contrast agent intravenously:\r\n** Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2\r\n** Sickle cell disease\r\n** Hemolytic anemia
Patients must be judged to be suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):\r\n* No history of untreatable claustrophobia\r\n* No presence of metallic implants that, in the opinion of the radiologist, would make MRI a contraindication\r\n* No history of sickle cell disease\r\n* No contraindication to intravenous contrast administration;\r\n* No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance\r\n* No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2 based on a serum creatinine level obtained within 28 days prior to registration\r\n* Weight lower than that allowable by the MRI table
Undergone a non-contrast chest CT in a time frame that will accommodate experimental imaging (s-DCT) within 2 weeks
Contraindication to use of gadolinium based intravenous contrast, including life threatening allergy or compromised renal function (creatinine > 2.0)
History of renal insufficiency (only for MRI contrast administration)
Patient is unable to undergo contrast-enhanced CT
Allergy to CT contrast media requiring the administration of steroid prophylaxis
Not suitable to undergo MRI with an extracellular gadolinium-based contrast agent that does not have dominant hepatobiliary excretion because of:\r\n* Claustrophobia, unless patient agrees to sedation measures per institutional standard practice during MR imaging\r\n* Presence of metallic objects or implanted medical devices in body per institutional safety standards\r\n* Sickle cell disease\r\n* Weight greater than that allowable by the MR table
Not suitable to undergo CT with an iodinated contrast agent:\r\n* Weight greater than that allowable by the CT table
Known allergy-like reaction to contrast media (iodinated or extracellular gadolinium that does not have dominant hepatobiliary excretion) or moderate or severe allergic reactions to one or more allergens as defined by the ACR, and unwillingness to undergo pre-treatment as defined by the institution’s policy and/or ACR guidance
Subjects with a known contraindication to the standard MRI contrast agent (Gadavist, a gadolinium-based contrast agent) and/or a recent estimated glomerular filtration rate (eGFR) of 30 or less will be excluded from all DCE-MRIs, and will instead receive non-contrast MRIs at the DCE-MRI time points.
Allergy to intravenous CT contrast media
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium (Gd) contrast material
Patients with a contraindication to having MR imaging (e.g. pacemaker) or contrast MR administration (e.g. hypersensitivity to gadolinium or renal insufficiency above the institutional threshold for administration of contrast); patients with hypersensitivity to MR contrast may be able to participate if it has been established that premedication will mitigate the hypersensitivity reaction
PART B: Contra-indication to gadolinium contrast (e.g. chronic renal disease, prior allergic reaction) for patient studies
Known allergy to gadolinium containing contrast agents
Subjects who have had past allergic or other adverse reactions to intravenous injection of Magnevist® (gadopentetate dimeglumine) or other gadolinium-containing contrast agents
Subjects who have exhibited past allergic or other adverse reactions in response to intravenous injection of Magnevist (gadopentetate dimeglumine) or other gadolinium-containing contrast agents
Patient with known or highly suspected primary intracranial tumors (intra-axial or extra-axial) detected by previous CT or MRI examination who are scheduled to undergo a routine contrast-enhanced MRI
Patient with known severe adverse drug reaction or contraindication to Gadolinium-Based Contrast Agent
Patient having received any contrast agent within 48 hours prior to first study contrast agent injection scheduled for the study and patient expected to receive any other contrast agent within 24 hours of the last study contrast agent injection
Subjects with known hypersensitivity and allergy to gadolinium contrast agents
Documented or reported contrast allergy
Have a known allergy to iodinated contrast agent
Known prior allergic reaction to gadolinium-based magnetic resonance (MR) contrast agents
Allergy to iodine or gadolinium contrast that cannot be safely controlled with premedication
History of hypersensitivity to iodine
Progressive, radioactive iodine-refractory, loco-regional recurrent or metastatic disease.
Patients with severe allergic reactions to iodine contrast which cannot be controlled by premedication with antihistamines and steroids.
Allergy to iodine; (NOTE: this does not include reactions to intravenous contrast materials)
Patients unable to follow a low iodine diet or requiring medication with high content in iodide (amiodarone)
Previous failure of iodine-131 (131I) therapy or not candidates to receive 131I as assessed by treating physician
Patients in which iodine contrast is contraindicated
Allergy to iodine; Note: this does not include reactions to intravenous contrast materials
One or more evaluable or measurable lesions that do not demonstrate iodine uptake on any radioiodine scan; or
Cumulative activity of 131 iodine greater than 400 millicuries (mCi) or 14.8 gigabecquerels (GBq), with the last dose administered at least 6 months prior to study entry.
Patients unable to follow a low iodine diet or requiring medication with high content in iodide (amiodarone)
Patients who received iodinated intravenous contrast as part of a radiographic procedure within 3 months of study registration; those that have had iodinated intravenous contrast within this time frame may still be eligible if a urinary iodine analysis reveals that the excess iodine has been cleared after the last intravenous contrast administration
Allergy to iodine; this does not include reactions to intravenous contrast materials
Patients with severe allergic reaction to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids (because a hepatic angiogram is needed for the Delcath system procedure).
Unable to follow a low iodine diet or requiring medication with high content in iodide (e.g., amiodarone)
Received iodinated intravenous contrast within =< 2 months of registration; avoidance of iodinated oral contrast is also preferred but not strictly required for study enrollment; NOTE: those who have had iodinated intravenous contrast within this time frame may still be eligible if a urinary iodine analysis reveals that excess iodine has been cleared (defined as urinary iodine documented to be < 300 mcg/day by either a spot urinary iodine or 24-hour urinary iodine measurement)
No prior systemic therapy or iodine I 131 (I131) or chemoembolization treatment after surgery
Prior treatment with therapeutic dose of radioactive iodine (> 50 mCi) with evidence of RAI uptake on delayed scan, with progression within 12 months of RAI
Allergy to iodine\r\n* Note: This does not include reactions to intravenous contrast materials
Dose Escalation cohort only: Allergy to iodine; NOTE: this does not include reactions to intravenous contrast materials
The tumor is considered to be radioactive-iodine refractory by any of the following criteria:\r\n* Total lifetime dose of radioactive iodine > 600 mCi\r\n* Absent or insufficient radioactive iodine uptake in either all lesions or an index lesion which has never been resected or received external beam radiation therapy as documented on a radioactive iodine scan (insufficient uptake must be confirmed by either an endocrinologist or nuclear medicine physician)\r\n* Progression of disease (by imaging or thyroglobulin) within 6 months of radioactive iodine treatment\r\n* Fludeoxyglucose F 18 (FDG)-avid lesion (standard uptake variable maximum [SUVmax] >= 3) on a FDG-positron emission tomography (PET) scan
No recent treatment for thyroid cancer as defined as:\r\n* No radioactive iodine therapy is allowed if given < 3 months prior to initiation of this protocol therapy; a diagnostic study using < 10 mCi of radioactive iodine (RAI) is not considered radioactive iodine therapy\r\n* No external beam radiation therapy < 4 weeks prior to initiation of therapy on this protocol\r\n* No chemotherapy or targeted therapy (e.g., tyrosine kinase inhibitor) is allowed < 4 weeks prior to the initiation of therapy
Willingness to maintain a low iodine diet for 12 days (starting 7 days prior to virus injection continuing until after the I131 radioiodine therapy on Day 5)
Goggle assessment substudy: iodine or seafood allergies
Patients unable to follow a low iodine diet or requiring medication with high content in iodide (amiodarone)
Patients who received iodinated intravenous contrast as part of a radiographic procedure within 3 months of study registration; those that have had iodinated intravenous contrast within this time frame may still be eligible if a urinary iodine analysis reveals that the excess iodine has been adequately cleared after the last intravenous contrast administration
Patients in whom iodine contrast is contraindicated
An allergy to iodine
Patients who have been treated with radioactive iodine within 24 weeks prior to study enrollment (radioactive iodine within 24 weeks will be allowed if negative post-treatment scan or progressive disease defined by RECIST 1.1)
Patient must have radioiodine refractory disease as defined by one or more of the following conditions:\r\n* All cases of medullary thyroid carcinoma\r\n* No iodine-uptake on a post-radioactive iodine treatment scan (in presence of low iodine diet and thyroid stimulating hormone [TSH] suppression) in an anatomically defined lesion that qualifies as target lesion by RECIST criteria, OR\r\n* If there is demonstrable iodine-uptake: the last radioiodine therapy of (>= 100 mCi) was given within the last 16 months OR if given more than 16 months before enrollment, there is evidence of disease progression after each of the last two radioiodine treatment performed within 16 months of each other (each dose should be >= 100mCi), OR\r\n* If the patient has received the maximum cumulative life time dose of radioactive iodine treatments of at least 600 mCi\r\n* If the patient declines or is intolerant of radioiodine therapy or if with progressive disease that is, in the opinion of the treating physician, likely to benefit from biologic therapy rather than further iodine therapy e.g. patient with heavy burden of disease
Within 18 months of enrollment, patients must have had a radioactive iodine (RAI) scan, showing no or therapeutically insignificant RAI uptake (=< 1%)
Subject has a known history contraindicating contrast dye or iodine that cannot be safely controlled via antihistamine, steroids, or with any other agent.
Has known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
History of iodine hypersensitivity
Patients in which iodine contrast is contraindicated
Known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
Patients must have previously received standard systemic therapy for advanced thyroid cancer (to include radioactive iodine for iodine-avid tumors and surgery [if indicated]) and have been either non-responders (progressive disease) or have recurred
Subjects who are pregnant or may become pregnant during metformin administration in accordance with radioactive iodine treatment guidelines
Women with dialysis, chronic urinary infection, hyperthyroidism, current infection, or a history of allergy or sensitivity to iodine will not be eligible to participate
Patients with a history of skin allergy to iodine or adhesive drapes
Women with a known allergy to proflavine, acriflavine, or iodine
Known prior allergic reaction to ICG or allergy to iodine
Patients unable to follow a low iodine diet or requiring medication with high content in iodide (amiodarone)
Patients who received iodinated intravenous contrast as part of a radiographic procedure within 3 months of study registration; those that have had iodinated intravenous contrast for CT imaging within this time frame may still be eligible if a urinary iodine analysis reveals that the excess iodine has been adequately cleared after the last intravenous contrast administration
Women with iodine contrast allergy
Have had allergic response to contrast agents (such as iodine or gadolinium) previously
Known allergy to iodine or intravenous contrast agent.
Allergic reaction to iodine-containing contrast material
History of allergy to iodine
Previous or on-going radioactive iodine treatment.
The patient has known or suspected allergies to iodine, indocyanine green (ICG) or isosulfan blue (ISB)
history of hypersensitivity to iodine
Iodine allergy, hyperthyroidism, or Grave’s disease
Contraindication for oral potassium iodine administration
The patient has a documented intravenous contrast allergy or iodine allergy
History of iodine hypersensitivity
Participants with a known or suspected allergy to iodine
History of hypersensitivity to iodine.
Participants must be Iodine-131 refractory/resistant as defined by at least one of the following:
One or more measurable lesions that do not demonstrate iodine uptake on any radioiodine scan.
Cumulative activity of Iodine-131 of >600 mCi or 22 gigabecquerels (GBq), with the last dose administered at least 6 months prior to study entry.
Any known allergy or prior reaction to fluorescein
Any known allergy or prior reaction to fluorescein, iodine, or shellfish
To determine any sensitivity to fluorescein, subject must have a skin prick test preoperatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given); a negative skin prick test to fluorescein is an inclusion criteria
Any known allergy or prior reaction to fluorescein; also, a positive skin prick test to fluorescein is considered an exclusion criteria and the patient would not be eligible for entry into this study
Allergy to fluorescein
Patient must not have a documented reaction to fluorescein (fluorescein sodium)