Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:\r\n* Brain metastases which have been treated\r\n* No evidence of disease progression for >= 3 months before the first dose of study drug\r\n* No hemorrhage after treatment\r\n* Off-treatment with dexamethasone for 4 weeks before administration of the first dose of TAK-228\r\n* No ongoing requirement for dexamethasone or anti-epileptic drugs
Symptomatic brain metastases or any leptomeningeal metastasis that is symptomatic and/or requires treatment. Subjects with brain metastases are eligible if these have been locally treated (surgery, radiotherapy). There must also be no requirement for immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone equivalent) for at least 2 weeks before the first dose of study treatment
Prior treated brain or meningeal metastases must be without evidence of progression (confirmed by MRI) for at least 8 weeks and off immunosuppressive doses of systemic steroids (greater than 10 mg/day prednisone or equivalent) for at least 4 weeks before study drug administration
Patients are excluded if they have active brain metastases or leptomeningeal metastases; subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for [lowest minimum is 4 weeks or more] after treatment is complete and within 28 days prior to the first dose of nivolumab administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms; patients with a history of treated central nervous system (CNS) metastases are eligible; treated brain metastases are defined as those having no evidence of progression for >= 1 month after treatment, or hemorrhage for >= 2 weeks after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or CT scan) during the screening period; any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for >= 2 weeks before the first study drug; treatment for brain metastases may include whole brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 1 month before day 1 of study treatment will be excluded
Patients with known brain metastases unless treated with an appropriate modality with no evidence of progression/recurrence for > 3 months
Known central nervous system (CNS) disease, except for treated brain metastasis: Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; gamma knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded
Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met: a) Brain metastases which have been treated b) No evidence of disease progression for >= 3 months before the first dose of study drug. c) No hemorrhage after treatment d) Off-treatment with dexamethasone for 4 weeks before administration of the first dose of TAK-228 e) No ongoing requirement for dexamethasone or anti-epileptic drugs.
Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of disease for 4 weeks after treatment is complete and within 28 days prior to the first dose of nivolumab. Subjects with asymptomatic brain metastases are eligible, though if treated with radiation or surgery the above criteria apply regarding a 28-day washout and MRI to assess for progression after 4 weeks.
Patients with treated brain metastases will be re-screened (MRI brain or CT head with IV contrast); patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by MRI/CT for at least two weeks prior to the first dose of study drug), have no evidence of new or enlarging brain metastases and are off systemic steroids (=< 10 mg/day prednisone or equivalent) for at least one weeks prior to enrollment
Note: Patients with previously treated brain metastases may participate, 2 weeks after gamma knife (or equivalent) or 4 weeks after whole brain radiotherapy (WBRT), provided they are stable (without evidence of progression by imaging and have not been using steroids for at least 7 days prior to study treatment
Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms; participants with a history of treated central nervous system (CNS) metastases are eligible; treated brain metastases are defined as those having no evidence of progression for >= 1 month after treatment, and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or computed tomography [CT] scan) completed during screening; any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for >= 2 weeks prior to registration; treatment for brain metastases may include whole brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician; participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 2 months before day 1 will be excluded
Patients are excluded if they have active brain metastases or leptomeningeal metastases; subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 4 weeks or more after treatment is complete and within 28 days prior to the first dose of nivolumab administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Patients with history of brain metastases except those with meningeal carcinomatosis or leptomeningeal disease may be eligible for treatment a minimum of 1 week following completion of gamma knife or whole brain radiotherapy, or 4 weeks following surgical resection of brain metastasis provided post-treatment magnetic resonance (MR) scan reveals no evidence of active disease, and no ongoing need for systemic steroids
Patients are excluded if they have active brain metastases or leptomeningeal metastases; subjects with brain metastases are eligible if metastases have been treated and there is no imaging evidence of progression for 28 days after treatment is complete and within 28 days prior to the first dose of nivolumab administration
Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:\r\n* Brain metastases which have been treated\r\n* No evidence of disease progression for >= 3 months or hemorrhage after treatment\r\n* Off-treatment with dexamethasone for 4 weeks before administration of the first dose of TAK-228\r\n* No ongoing requirement for dexamethasone or anti-epileptic drugs
Subjects with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery (SRS) at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intracranial disease
Patients with melanoma brain metastases are allowed; subjects with brain metastases are eligible if (a) metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 4 weeks after treatment is complete and within 28 days of the first dose of nivolumab administration; or (b) if they are untreated but asymptomatic or c) if they are untreated and symptomatic but symptoms are controlled on stable or decreasing doses of steroids for 14 days prior to drug administration; patients are excluded if they require high doses of systemic corticosteroids (> 8 mg equivalent of dexamethasone) to control central nervous system (CNS) symptoms
Prior treated brain metastases are allowed; however, prior treated brain metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks and off systemic steroids for at least 2 weeks before study drug administration
Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:\r\n* Brain metastases which have been treated\r\n* No evidence of disease progression for >= 4 weeks or hemorrhage after treatment\r\n* Off-treatment with dexamethasone for 2 weeks before administration of the first dose of MLN0128\r\n* No ongoing requirement for dexamethasone or anti-epileptic drugs
Prior treated brain or meningeal metastases must be without MRI evidence of progression for at least 8 weeks and off systemic steroids for at least 2 weeks prior to screening/baseline.
Patients are excluded if they have active brain metastases or leptomeningeal metastases; subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to the first dose of nivolumab administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Patients are excluded if they have active brain metastases or leptomeningeal metastases; subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 2 weeks of more after treatment is complete and within 28 days prior to the first dose of nivolumab administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Subjects with no brain metastases or a history of previously treated brain metastases who:\r\n* Have been treated by surgery or stereotactic radiosurgery (SRS) at least 4 weeks prior to enrollment\r\n* AND have a baseline magnetic resonance imaging (MRI) that shows no evidence of active intercranial disease\r\n* AND have not had treatment with steroids for brain metastases within 1 week of study enrollment
Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 4 weeks or more after treatment is complete and within 28 days prior to the first dose of nivolumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
Known central nervous system (CNS) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded.
Patients are excluded if they have active brain metastases or leptomeningeal metastases; subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 14 days prior to initiation of treatment
Patients are excluded if they have active, symptomatic brain metastases or leptomeningeal metastases; subjects with known brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for four weeks (after treatment is complete and within 28 days prior to study drug administration)
Active central nervous system (CNS) metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for (lowest minimum is 4 weeks or more) after treatment is complete and within 28 days prior to the first dose of nivolumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
Active brain metastasis or leptomeningeal disease; patients with known brain metastases are allowed if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 12 weeks after treatment is complete and within 28 days prior to the first dose of nivolumab administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Subjects with no brain metastases or a history of previously treated brain metastases who:\r\n* Have been treated by surgery or stereotactic radiosurgery (SRS) at least 4 weeks prior to enrollment\r\n* AND have a baseline magnetic resonance imaging (MRI) that shows no evidence of active intracranial disease\r\n* AND have not had treatment with steroids within 1 week of study enrollment\r\n* Neuroblastoma (NB): Concurrent use of steroids as a supportive medication, e.g. for appetite stimulation is allowed, but must comply with the doses listed
Patients with known brain metastases or leptomeningeal metastases are excluded unless the following conditions are met:\r\n* Metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment is complete (must be confirmed within 28 days prior to the first dose of nivolumab administration) \r\n* There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Prior treated brain or meningeal metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks before study drug administration
Prior treated brain or meningeal metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks before study drug administration\r\n* For the current amendment 7, up to ten patients may be included in cohort 6 that have four or fewer untreated brain metastases, with no lesion larger than 2 cm, and no evidence of cerebral edema requiring steroids
Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms; participants with a history of treated central nervous system (CNS) metastases are eligible; treated brain metastases are defined as those having no evidence of progression for >= 1 month after treatment, and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or computed tomography [CT] scan) completed during screening; any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for >= 2 weeks prior to registration; treatment for brain metastases may include whole brain radiotherapy, radiosurgery, surgery or a combination as deemed appropriate by the treating physician
Prior treated brain or meningeal metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks before study drug administration
Patients are excluded if they have active brain metastases or leptomeningeal metastases; subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for (lowest minimum is 4 weeks or more) after treatment is complete and within 28 days prior to the first dose of nivolumab administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Patients are excluded if they have active brain metastases or leptomeningeal metastases; subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 6 months after treatment is complete and within 28 days prior to the first dose of nivolumab and bevacizumab administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Known central nervous system (CNS) disease, except for treated brain metastasis; treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period; anticonvulsants (stable dose) are allowed; treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded
Known brain metastases or leptomeningeal metastases; NOTE: symptomatic, and/or if they require immunosuppressive doses of corticosteroids (e.g. > 10 mg/day prednisone or equivalents) for at least 2 weeks prior to study drug administration; patients with treated brain metastases who are deemed clinically stable and without radiological progression on positron emission tomography (PET), MRI or computed tomography (CT) scan performed =< 8 weeks of study entry, are not excluded; NOTE: primary nasopharyngeal cancers that directly invade the skull base and extend into the infratemporal fossa (e) are not regarded as brain metastases and are not excluded
Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and have been stable for at least three months prior to registration; eligible subjects should be neurologically asymptomatic; there is no magnetic resonance imaging (MRI) evidence of progression for a minimum of 4 weeks after treatment is complete and within 28 days prior to the first dose of nivolumab administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Subjects with a history of brain metastasis are eligible for the study as long as they meet all the following criteria: their brain metastases have been treated, they have no evidence of progression or hemorrhage after treatment, have been off dexamethasone for 4 weeks prior to first study drug administration, and have no ongoing requirement for dexamethasone or anti-epileptic drugs;
Subjects with no brain metastases or a history of previously treated brain metastases who:\r\n* Have been treated by surgery or stereotactic radiosurgery (SRS) at least 4 weeks prior to enrollment\r\n* AND have a baseline magnetic resonance imaging (MRI) that shows no evidence of active intracranial disease\r\n* AND have not had treatment with steroids within 1 week of study enrollment\r\n* Neuroblastoma (NB): Concurrent use of steroids as a supportive medication, e.g. for appetite stimulation is allowed, but must comply with the doses listed
Known central nervous system (CNS) disease, except for treated brain metastases; treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period; anticonvulsants (stable dose) are allowed; treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day -3 will be excluded
Known central nervous system (CNS) disease, except for treated brain metastasis; treated brain\r\nmetastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period; anticonvulsants (stable doses) are allowed; treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed < 4 weeks prior to Day 1 will be excluded
Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573
History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 weeks prior to the first dose of study drug; screening with CNS imaging studies (CT or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases; treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period; anticonvulsants will not be allowed; treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; gamma knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded
EXPANSION COHORT ONLY: History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 weeks prior to the first dose of study drug; screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases; treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period; anticonvulsants will not be allowed; treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; gamma knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded
History of leptomeningeal carcinomatosis or active brain metastases receiving concurrent treatment inclusive of but not limited to surgery, radiation and/or corticosteroids; Note: brain metastases that have been treated for anticancer purposes where there has been no magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks after treatment are permitted on study
Subjects with no brain metastases or a history of previously treated brain metastases who:\r\n* Have been treated by surgery or stereotactic radiosurgery (SRS) at least 4 weeks prior to enrollment\r\n* AND have a baseline magnetic resonance imaging (MRI) that shows no evidence of active intracranial disease\r\n* AND have not had treatment with steroids for brain metastases within 1 week of study enrollment
Active brain metastases or leptomeningeal metastases (carcinomatous meningitis); subjects with brain metastases are eligible if these have been treated and there is no evidence of progression for at least 2 weeks after treatment is complete and corticosteroid dose is stable (and equivalent dose of < 10 mg prednisone) for at least 2 weeks
Patients with known brain metastases unless treated with an appropriate modality with no evidence of progression/recurrence for > 3 months
Active brain metastases or leptomeningeal metastases; subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 42 weeks after treatment is complete and within 28 days prior to first dose of study drug administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalent) for at least 2 weeks prior to study drug administration
Active brain metastases (untreated brain metastases or growth on imaging as defined below) or leptomeningeal disease are not allowed; subjects with brain metastases are eligible if these have been treated and there is no MRI (or CT if MRI contraindicated) evidence of progression for at least 8 weeks after treatment for these metastases is complete and within 28 days prior to first study treatment
Subjects with no brain metastases or a history of previously treated brain metastases who:\r\n* Have been treated by surgery or stereotactic radiosurgery (SRS) at least 4 weeks prior to enrollment\r\n* AND have a baseline magnetic resonance imaging (MRI) that shows no evidence of active intra cranial disease\r\n* AND have not had treatment with steroids within 1 week of study enrollment\r\n* Neuroblastoma (NB): Concurrent use of steroids as a supportive medication, e.g. for appetite stimulation is allowed
Known central nervous system (CNS) disease, except for treated brain metastasis; treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period; anticonvulsants (stable dose) are allowed; treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS) (Gamma Knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded
Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study; patients with treated brain metastases can enter the study; treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period; anticonvulsants (stable dose) are allowed; treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded
Patients are excluded if they have active brain metastases or leptomeningeal metastases; subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for (lowest minimum is 4 weeks or more) after treatment is complete and within 28 days prior to the first dose of nivolumab administration; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Patients with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intracranial disease and have not had treatment with steroids within 1 week of study enrollment
Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:\r\n* Brain metastases which have been treated,\r\n* No evidence of disease progression for >= 3 months or hemorrhage after treatment,\r\n* Off-treatment with dexamethasone for 4 weeks before administration of the first dosing,\r\n* No ongoing requirement for dexamethasone or anti-epileptic drugs
Active brain metastases or leptomeningeal metastases; subjects with treated brain metastases are eligible if they meet all of the following criteria:\r\n* Must be at least 28 days since craniotomy and resection, stereotactic radiosurgery, or whole brain radiotherapy\r\n* Must have no evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to first dose of study drug administration\r\n* Must have no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Patients with active or untreated brain metastases or leptomeningeal metastases are excluded from this clinical trial; NOTE: patients with previously treated brain metastases must have stable neurologic status and magnetic resonance imaging (MRI) imaging following local therapy (surgery or radiation) for at least 4 weeks, with no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration (stable low dose dexamethasone allowed at discretion of protocol chair)
Has active brain metastases or leptomeningeal metastases. Participants with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (greater than [>] 10 milligram per day [mg/day] prednisone equivalents) for at least 2 weeks prior to study drug administration.
Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
Baseline imaging:
Patients must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for the treatment and the protocol
At least one lesion that can be accurately measured in two dimensions utilizing mammogram, ultrasound, or magnetic resonance imaging (MRI) images to define specific size and validate complete clinical and pathologic response
Patients must have T3/4 or N+ disease by magnetic resonance imaging (MRI) or endoscopic ultrasound
Ability to tolerate magnetic resonance imaging (MRI).
Patients not able to have a magnetic resonance imaging (MRI) (due to pacemaker, claustrophobia, etc.)
Patients must have measurable (defined by at least 1 cm x 1 cm) contrast-enhancing disease by magnetic resonance imaging (MRI) imaging within 21 days of starting treatment
Able to undergo a magnetic resonance imaging (MRI) scan and receive gadolinium-based contrast
Contraindication to magnetic resonance imaging (MRI)
For patients who have received prior cranial radiation, no increase in corticosteroid dose in the week prior to the baseline brain magnetic resonance imaging (MRI)
Patients must have a baseline evaluation including history and physical examination with neurological evaluation and magnetic resonance imaging (MRI) of the brain (with and without gadolinium-based contrast), all completed within 30 days prior to initiation of treatment
Participants with known spinal or distant metastases; patients with ependymoma, medulloblastoma or germinoma must have metastatic workup including spine magnetic resonance imaging (MRI) to rule out metastases
Evidence of disease activity as outlined (e.g. gadolinium enhancement on magnetic resonance imaging of the brain or clinical progression)
1-6 definitive intracranial lesions must be present on magnetic resonance imaging (MRI) of the brain
Cytologically-confirmed LMD or radiologically detectable LMD defined as either/or:\r\n* A measurable lesion on contrast-enhanced magnetic resonance imaging (MRI) of either the brain or total-spine > 3 mm that has not been radiated within the last 3 months prior to commencement of study therapy\r\n* Positive CSF cytology
Five-twenty intracranial lesions must be present on magnetic resonance imaging (MRI) of the brain
Experienced first unequivocal progression of tumor by magnetic resonance imaging (MRI) [as assessed via Radiologic Assessment in Neuro-Oncology (RANO) criteria within 3 months from the last dose of TMZ.
Optic pathway tumors, including chiasmatic-hypothalamic, tumor without histologic confirmation; patients with chiasmatic lesions with or without contiguous extension of tumor into other regions of the visual pathways demonstrated on contrast magnetic resonance imaging (MRI) will be eligible for study without histopathologic confirmation with or without NF-1
Patient must have magnetic resonance imaging (MRI) confirming progressive disease
Presence of T1 gadolinium (Gd)–enhancing lesions (on magnetic resonance imaging [MRI]) suggestive of high-grade glioma
Inability to undergo magnetic resonance imaging (MRI) evaluation for treatment planning and follow-up
Multicentric breast cancer in the ipsiltateral breast as diagnosed by clinical exam, mammogram, ultrasound or magnetic resonance imaging (MRI)
Patients must have measurable disease (in 2-dimensions) on magnetic resonance imaging (MRI) scan of brain and/or spine to assess preliminary evidence of response
Patients must be able to have magnetic resonance imaging (MRI) scans
Myometrial invasion > 50% or evidence of nodal or metastatic disease on baseline magnetic resonance imaging (MRI) (MRI only to be done for EC patients) or tumor size > 2 cm on MRI or pelvic ultrasound
Histologically proven adenocarcinoma of the lower rectum (lower border =< 6 cm from anal verge as assessed by pelvic magnetic resonance imaging [MRI]).
Is able to have magnetic resonance imaging (MRI) with contrast of the brain
Documented first or second recurrence of glioblastoma (GBM) by diagnostic biopsy or contrast enhanced magnetic resonance imaging (MRI) performed within 21 days of randomization per Response Assessment for NeuroOncology (RANO) criteria.
Brain magnetic resonance imaging (MRI) (or CT if contraindication to MRI) within the last 60 days showing no evidence of metastatic disease
Is unable (due to existent medical condition) or unwilling to have a contrast enhanced magnetic resonance imaging (MRI) of brain
Phase I patients must have measurable contrast-enhancing disease (defined as at least 1 cm x 1 cm) by magnetic resonance imaging (MRI) imaging within 21 days prior to starting treatment (patients may have gross total resection, but should have measurable disease post-operatively); patients must be able to undergo MRI of the brain with gadolinium
Patients must be able to undergo magnetic resonance imaging (MRI) scan with gadolinium contrast for treatment planning
Meet eligibility requirements for SRS: able to get magnetic resonance imaging (MRI), lesion must not be abutting optic apparatus or brainstem, and must be able to be secured and positioned in a stereotactic U-frame mask
Patients who cannot safely undergo magnetic resonance imaging (MRI) due to non-MRI compatible pacemaker, or other reason
Patient can’t have magnetic resonance imaging (MRI) scan
Patients with absolute contraindication to magnetic resonance imaging (MRI) imaging are not eligible for the study
Have an enhancing mass on magnetic resonance imaging (MRI) amenable to > 90% resection of contrast-enhancing tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior stereotactic biopsy
Patients with inability to complete brain magnetic resonance imaging (MRI) studies with contrast
A magnetic resonance (MR) scan must be obtained within 30 days of enrollment and must demonstrate an enhancing mass without significant mass effect; tumors must be less than approximately 32 cc in total volume, as assessed by the principal investigator (PI) based on pre-enrollment magnetic resonance imaging (MRI); the lesion must be stereotactically accessible
Participants must have locally advanced rectum cancer where primary resection without chemoradiotherapy (CRT) is unlikely to achieve clear margins as defined by magnetic resonance imaging (MRI), with no metastatic disease, as assessed by independent review.
Unifocal tumor =< 2 cm based on contrast-enhanced prone-breast magnetic resonance imaging (MRI)
As defined on magnetic resonance imaging (MRI), target lesion must be at least 10 mm distance from skin (defined as volume encompassing first 3 mm from breast surface)
The primary tumor must be measurable by an imaging modality prior to treatment; this imaging modality is to be repeated after completion of 4 cycles of paclitaxel and prior to surgery; such imaging modalities may include ultrasound, computed tomography (CT), mammography, or magnetic resonance imaging (MRI); MRI will be the preferred imaging modality if available; all imaging will be performed per standard of care at the discretion of the treating physicians
Be able to undergo a brain magnetic resonance imaging scan
Patients with untreated/active brain metastases as documented by magnetic resonance imaging (MRI) within 2 months of study enrollment
Able to undergo brain magnetic resonance imaging (MRI) with and without contrast without requiring general anesthesia
Patients unable to undergo magnetic resonance imaging (MRI) of the spine
Chest imaging (x-ray, CT or magnetic resonance imaging [MRI]) negative for metastasis no more than 6 weeks prior to the date of RPLND
Magnetic resonance imaging (MRI) findings consistent or with a histologically confirmed newly diagnosed GBM that has not been treated and would benefit from further surgical resection
Creatinine within normal institutional limits OR according to institutional magnetic resonance imaging (MRI) policy
Subjects must have suspected high grade glioma by magnetic resonance imaging (MRI)
Medical contraindication to undergoing magnetic resonance (MR) imaging
A contrast-enhanced magnetic resonance imaging (MRI) scan showing >= 4 treatable brain metastases
Patient must be able have a magnetic resonance imaging (MRI) of the brain for treatment planning
Patients with evidence of metastatic spinal disease by magnetic resonance imaging (MRI) are NOT eligible for either Stratum
Contraindication to magnetic resonance (MR) imaging
Histologically confirmed systemic malignancy with gadolinium contrast-enhanced magnetic resonance imaging (MRI) scan demonstrating 1-5 newly diagnosed intraparenchymal brain metastases
Patients must have measurable lesion in the brain or spine that is >= 3 mm seen on magnetic resonance imaging (MRI) with contrast; NOTE: contrasted pre-treatment MRI scan must be obtained =< 21 days prior to stereotactic radiosurgery treatment
Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3 by magnetic resonance imaging (MRI), with and without contrast sequences; axial T2 sequence is encouraged but not required
Stage IV metastatic disease with intracranial disease visible with magnetic resonance image (MRI)
Any contraindication to MRI (i.e. patients with pacemakers or other metal implanted medical devices); an MRI safety questionnaire is required prior to magnetic resonance (MR) imaging
No evidence of extraprostatic disease on 3T multiparametric pelvic magnetic resonance imaging (MRI)
Radiographic evidence by magnetic resonance imaging (MRI) of brain metastasis (if patient is unstable to tolerate contrast, an MRI without contrast is acceptable)
Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-2, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including magnetic resonance imaging (MRI) and/or endorectal ultrasound
Presence of any contraindications to magnetic resonance imaging (MRI) scanning
Patients must have disease that can be measured and followed by mammogram and/or breast ultrasound (in special cases a dedicated breast magnetic resonance imaging [MRI] may be clinically indicated); the target lesion must not have been previously irradiated
Patient has no contraindications to magnetic resonance imaging (MRI) scanning with intravenous contrast
Rectal cancer originally staged as T1, T2, or T3, node negative (N0) or node positive (N1, N2) by pelvic magnetic resonance imaging (MRI)
Inability to undergo magnetic resonance imaging
Eligible for contrasted magnetic resonance imaging (MRI) on initial evaluation with glomerular filtration rate (GFR) >= 60 ml/min; a diagnostic MRI ordered within 60 days of diagnosis will be considered an acceptable alternative and will not be repeated
Magnetic resonance imaging (MRI) is required for radiation treatment planning on this study; a diagnostic MRI performed within 60 days of obtaining consent is acceptable and will not be repeated; subjects who have not had a diagnostic MRI will be required to have a research treatment planning MRI with contrast ordered by a radiation oncologist; these subjects must have a glomerular filtration rate (GFR) >= 60 ml/min
Surgery: at least 2 weeks following surgery including brain and spine provided post-operative magnetic resonance imaging (MRI) shows no active bleeding
Imaging by magnetic resonance imaging (MRI), ultrasound and/or mammogram and physical exam to document lesions size must be performed within 30 days of study entry
Able to undergo brain magnetic resonance imaging (MRI) with and without contrast
Centrally located tumors with radiographic evidence (CT or magnetic resonance imaging [MRI]) of local invasion of major blood vessels
Unable to undergo magnetic resonance imaging (MRI) imaging
Prospective participant is unable to undergo a magnetic resonance imaging (MRI) with contrast agent
Gross disease must be unifocal on mammogram (mammo)/magnetic resonance imaging (MRI) imaging
If consenting to participate in the optional PET/MR imaging sub-study, the patient must be able to tolerate PET/magnetic resonance imaging (MRI) with intravenous contrast administration and must complete the applicable MRI screening evaluation form
Eligibility for stereotactic radiosurgery using magnetic resonance imaging (MRI) targeting: The decision to treat with stereotactic radiosurgery will be made by a consensus of the radiation oncology, neurosurgery and neuro-oncology providers or their alternates at the weekly Brain Tumor or Stereotactic Radiosurgery Tumor Conferences; all patients must have no restrictions to obtaining MRI with and without paramagnetic contrast
Any contraindication to MRI (i.e. patients with pacemakers or other metal implanted medical devices); an MRI safety questionnaire is required prior to magnetic resonance (MR) imaging
Residual lesion must be >= 1.0 cm in diameter as determined by magnetic resonance imaging (MRI)
Measurable disease on magnetic resonance imaging (MRI) scan
Patients must have had a bilateral diagnostic mammogram within 6 months of registration, and may also have a targeted sonography of the breast and/or ipsilateral axilla and magnetic resonance imaging (MRI) if clinically indicated
Patients must have bilateral mammogram and/or breast magnetic resonance imaging (MRI) within 3 months of diagnosis of their breast cancer
Any contraindication for undergoing magnetic resonance imaging (MRI)
All patients must have greater than 3 but less than or equal to 15 metastatic lesions seen on a contrast enhancing magnetic resonance imaging (MRI) scan obtained not less than one month prior to study enrollment; patients who are found to have up to 20 metastatic lesions at the time of treatment planning (on volumetric MRI once the head frame is in place) may still participate in the trial
Consensus of diagnosis must be reached by a multidisciplinary pediatric neuro-oncology team by considering both clinical evidence and magnetic resonance imaging (MRI) presentation; tissue diagnosis is not required
There must be measurable disease on magnetic resonance imaging (MRI)
Evidence of a new intracranial or intratumoral hemorrhage that is larger than a punctuate size on baseline magnetic resonance imaging (MRI) obtained within 14 days prior to study registration
Imaging studies: brain magnetic resonance imaging (MRI) before start of protocol therapy; images must include T1, T1 with gadolinium, T2, and fluid attenuated inversion recovery (FLAIR) sequences
Inability to tolerate periodic magnetic resonance imaging (MRI) scans or gadolinium contrast
Newly diagnosed brain metastases (four or fewer by postcontrast magnetic resonance imaging [MRI] obtained within six weeks of study entry)
Contraindication to magnetic resonance imaging (MRI) contrast agents
There must be measurable contrast-enhancing progressive or recurrent GBM (single or multiple lesions) by magnetic resonance imaging (MRI) imaging with an interval of greater than or equal to 6 months between recurrence and completion of prior radiotherapy; while there is no defined maximum tumor volume for eligibility in this study, patients with diffuse, multifocal recurrences may be excluded at the discretion of the study principle investigator (PI); there must be an MRI performed within 4 weeks prior to any therapy
Patients are excluded if they are unable to obtain a Magnetic resonance imaging (MRI) scan for any other reason.
Contraindication for undergoing magnetic resonance imaging (MRIs)
Contraindication to magnetic resonance imaging (MRI), including presence of a pacemaker or aneurysm clip, severe claustrophobia, a known reaction to gadolinium contrast, or body weight exceeding 300 pounds (lbs)
Inability or unwillingness to have magnetic resonance imaging (MRI) scans performed (e.g. cardiac pacemaker-dependent)
Patients must have magnetic resonance imaging (MRI) within 21 days of starting treatment; patients must be able to tolerate MRI
Participants with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of progressive disease based upon nuclear imaging, magnetic resonance (MR) spectroscopy, perfusion imaging or histopathology
Inability to undergo magnetic resonance (MR) imaging to assess disease status
Patients must be able to undergo magnetic resonance imaging (MRI) of the brain with gadolinium
Patients must meet both of the first two conditions, OR the third:\r\n* Clinical findings consistent with a presumed new diagnosis of diffuse midline glioma (DMG) in the opinion of the treating neuro-oncologist, AND\r\n* Brain magnetic resonance imaging (MRI) findings consistent with a new diagnosis of DMG based on multidisciplinary consensus after review of imaging \r\n* OR, recurrent DMG requiring tumor resection or biopsy
Documented recurrence by diagnostic biopsy or contrast enhanced magnetic resonance imaging (MRI) performed within 28 days of entry in to the trial as per Response Assessment Criteria for High-Grade Gliomas (RANO) criteria
Patients must have histologically or cytologically confirmed malignancy (not leukemia or lymphoma); there must be metastatic brain disease apparent on magnetic resonance imaging (MRI) which offers a medical indication for brain radiation
Magnetic resonance imaging (MRI) performed within 4 weeks of trial enrollment
Arm 1 patients must have measurable (defined by at least 1 cm x 1 cm) contrast-enhancing disease by magnetic resonance imaging (MRI) imaging within 21 days of starting treatment
Patients who cannot undergo brain magnetic resonance imaging (MRIs)
If applicable, patients must be off bevacizumab therapy for 30 days before the baseline magnetic resonance imaging (MRI) is obtained
Radiologically confirmed metastatic brain lesion by magnetic resonance imaging (MRI)
Patient is unable to undergo a magnetic resonance imaging (MRI)
Contraindication for magnetic resonance imaging (MRI)
Spinal compression or structurally unstable bone lesions suggesting impending pathologic fractures based on clinical findings and/or magnetic resonance imaging (MRI)
>1 focal lesions detected by functional imaging including PET/CT and/or whole body magnetic resonance imaging (MRI) AND have measurable disease by protein electrophoresis analyses as defined by the following:
A histologically proven, clinically significant lesion visible on mpMRI (magnetic resonance imaging) that is accessible to PRX302 transperineal injection.
Cohort A: Histologically confirmed metastatic non-small cell lung cancer (all histologic subtypes allowed) with radiographic evidence by magnetic resonance imaging (MRI) of at least one measurable brain lesion as defined by Response Assessment in Neuro-Oncology (RANO) criteria that does not require corticosteroids for symptomatic control
Documented recurrence by diagnostic biopsy or contrast enhanced magnetic resonance imaging (MRI) performed within 28 days of entry in to the trial as per Response Assessment in Neuro-Oncology (RANO) criteria
Patients must have undergone an evaluation by magnetic resonance imaging (MRI) within 35 days of completing radiation and must also be within 7 days prior to registration; MRI must NOT demonstrate tumor progression, but patients with imaging changes consistent with pseudo-progression, stable neurologic function and not needing corticosteroid treatment are eligible
Histologically confirmed primary invasive adenocarcinoma of the breast with the size of the primary tumor being at least 1 cm on imaging by either mammography, ultrasound or breast magnetic resonance imaging (MRI)
Centrally located tumors with radiographic evidence (CT or magnetic resonance imaging [MRI]) of local invasion of major blood vessels
Documentation of mammogram, ultrasound and magnetic resonance imaging (MRI) of the ipsilateral breast all performed within 42 days prior to registration
Absence > 1 focal lesions on magnetic resonance imaging (MRI) studies
No centrally located tumors with radiographic evidence (CT or magnetic resonance imaging [MRI]) of local invasion of major blood vessels
Patients unable to obtain magnetic resonance imaging (MRI) for any reason (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity)
At least one recurrent or progressive brain metastasis(es) from any solid primary tumor that is visible on magnetic resonance imaging (MRI) as assessed by the patient’s treating physician
Inability to undergo magnetic resonance imaging
Patients with newly diagnosed DIPG, who undergo a biopsy are eligible; patients with disseminated disease are not eligible, and magnetic resonance imaging (MRI) of the spine must be performed if disseminated disease is suspected by the treating physician
Clinical stage II-IIIC (T2-4 N0-3 M0) by mammogram, ultrasound or magnetic resonance imaging (MRI)
There must be documented progression or recurrence of disease by magnetic resonance imaging (MRI) imaging or cerebrospinal fluid (CSF) studies since completion of last tumor-directed medical therapy; patients may have had surgical resection or radiation of tumor, and need not have measurable or evaluable disease at study entry
Phase Ib and II: surgical candidates, with moderate to high-risk pathologically-confirmed rectal cancer (stage cT3-4N0 or cT1-4N+); clinical staging by endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) is permitted
Inability or unwillingness to have magnetic resonance imaging (MRI) scans performed (e.g. cardiac pacemaker-dependent)
Patient who is unable to undergo magnetic resonance imaging (MRI) brain and spine with gadolinium contrast.
No increase in corticosteroid dose in the week prior to the baseline brain magnetic resonance imaging (MRI)
Patient must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol
Patients must have measurable disease, defined as at least one vestibular schwannoma (VS) > 0.4 ml (on volumetric analysis) that can be accurately measured by contrast-enhanced cranial magnetic resonance imaging (MRI) scan with fine cuts through the internal auditory canal (3 mm slices, no skip)
Patients must have unequivocal evidence of tumor progression by magnetic resonance imaging (MRI) performed no longer than 28 days prior to study registration
Able to undergo brain magnetic resonance imaging (MRI) with and without contrast
Patients must have a baseline evaluation including history and physical examination with neurological evaluation and magnetic resonance imaging (MRI) of the brain (with and without gadolinium-based contrast), all completed within 30 days prior to initiation of treatment
Patients with greater than 9 discrete metastases on magnetic resonance imaging (MRI)
Diagnostic imaging: Baseline magnetic resonance imaging (MRI) of the brain and spinal axis with gadolinium and prior to any chemotherapy is required; if surgical resection is performed, a post operative MRI is required; if the patient receives chemotherapy prior to radiation, a post-chemotherapy MRI of the brain is required; if spinal involvement was seen on initial MRI and prior to chemotherapy, a MRI of the spine is required after chemotherapy and prior to radiation
Patients with untreated central nervous system (CNS) metastases; patients should have a head CT/magnetic resonance imaging (MRI) within 28 days prior to treatment initiation; patients with previously excised/gamma knifed solitary or oligometastases and controlled disease are eligible
Patients must be able to undergo an magnetic resonance imaging (MRI) scan
Patients must have MS using McDonald criteria supported by characteristic magnetic resonance imaging (MRI) changes
Patients must agree to undergo repeat clinical neurological examinations and brain magnetic resonance imaging (MRI) with appropriate contrast after every other cycle of chemotherapy
Patients must be able to undergo a pre-surgical magnetic resonance imaging (MRI) brain
Patients meeting the following exclusion criteria will be excluded from the magnetic resonance imaging (MRI) portion only: \r\n* Metallic implant, e.g. pacemaker, defibrillator \r\n* Unmanageable claustrophobia \r\n* High risk for nephrogenic systemic fibrosis
Patients with >= 5 measurable brain metastases on a diagnostic-quality contrast-enhanced magnetic resonance imaging (MRI) obtained within 30 days prior to registration
Contraindication to magnetic resonance (MR) imaging, such as implanted metal devices or foreign bodies, severe claustrophobia, or contraindications to contrast agent administration
No brain metastases detected by magnetic resonance imaging (MRI).
Patients must have measurable disease on magnetic resonance imaging (MRI) that has progressed after prior therapy; progressive disease (PD) will be defined as a >= 25% increase in the sum of the products of greatest perpendicular diameters of all measurable disease over the smallest sum observed (since treatment started) on gadolinium magnetic resonance imaging (Gd-MRI), the appearance of new lesions on scan, or clinical or neurologic worsening despite stable disease on the last 2 scans
Contraindication to magnetic resonance imaging
Patients must have measurable contrast-enhancing disease by magnetic resonance imaging (MRI) imaging within 21 days of starting treatment; patient must be able to undergo MRI of the brain with gadolinium
Brain magnetic resonance imaging (MRI) documenting CR must be obtained within 30 days of study enrollment
Patients with extraocular disease evident on magnetic resonance imaging (MRI) (extension into the optic nerve), massive choroidal/uveal invasion (grade IIC or IID per ARET0332) or disease outside the globe evident on MRI or physical examination would also be excluded
Documentation by magnetic resonance (MR) of a gadolinium-enhancing intraparenchymal mass consistent with malignant glioma
Medical contraindication to undergoing magnetic resonance (MR) imaging
Known allergies against contrast agents required for magnetic resonance imaging (MRI) of intracranial lesions, or other contraindications for MRI, i.e., pacemaker
A cardiac T2* <10 ms by magnetic resonance imaging (MRI).
Patients must have magnetic resonance imaging (MRI) within 21 days of starting treatment
Patients must be able to undergo brain or spine magnetic resonance imaging (MRI) scans with intravenous gadolinium, based on tumor location(s) within 14 days prior to registration
Phlebotomy-dependent participants with splenomegaly by magnetic resonance imaging (MRI) or computerized tomography (CT) imaging (? 450 cubic centimeters [cm^3]) or without splenomegaly (< 450 cm^3, unpalpable, or prior splenectomy)
Patient is able to be assessed by periodic dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) scan
Patients must have measurable progressive or recurrent disease by magnetic resonance imaging (MRI) within 2 weeks of starting treatment
Unable to undergo brain magnetic resonance imaging (MRI)
Patients must have a magnetic resonance imaging (MRI) scan performed within 14 days prior to initial protocol treatment
In patients with CNS tumors or known CNS metastases, evidence of intracranial or intratumoral hemorrhage of more than punctuate size and/or more than 3 foci of punctuate hemorrhage on baseline magnetic resonance imaging (MRI) obtained within 14 days prior to study registration
No contraindications for magnetic resonance imaging (MRI) (e.g., unsafe MRI implanted devices, shrapnel, history of metal fragments in eyes, neurostimulators, excessive size and weight, claustrophobia)
A diagnostic contrast-enhanced magnetic resonance imaging (MRI) of the brain must be performed within 28 days prior to registration
Patients at institutions that elect to utilize central imaging review to confirm eligibility must be pre-registered prior to submission of these images; images should be submitted as soon as possible after the pre-registration magnetic resonance imaging (MRI) is obtained; turnaround time for this review will be =< 72 business hours after receipt of images by the Imaging and Radiation Oncology Core (IROC)
Patients must be receiving magnetic resonance imaging (MRI) scans at University of California San Francisco (UCSF)
Stable dose of corticosteroids for >= 5 days prior to baseline magnetic resonance imaging (MRI)
Confirmed primary brain tumor diagnosis via magnetic resonance imaging (MRI) and their neuro-oncologist
Magnetic resonance imaging (MRI)-incompatible head or neck tattoos
Additional exclusion criteria include participation in a scheduled resistance exercise program within 1 month of study entry; metal implants or other contraindications for the magnetic resonance imaging (MRI); history of diabetes, chronic renal disease characterized by a creatinine clearance of less than 30, uncontrolled hypertension; and a vitamin D status (25(OH)D) of > 32ng/mL
Patients unable to undergo magnetic resonance imaging (MRI) of the spine
Contraindication to magnetic resonance (MR) imaging such as implanted metal devices or foreign bodies
For the subset of participants who will undergo magnetic resonance imaging (MRI), ability to withstand lying down in small area (MRI scanner) for 50 minutes
Subjects should have breast and axillary imaging with breast magnetic resonance imaging (MRI) (preferred) or breast and axillary ultrasound (US) within 4 weeks prior to treatment initiation
Acute ischemic stroke within the prior four weeks, defined as a new neurologic deficit(s) with magnetic resonance imaging (MRI) evidence of acute ischemia in a referable location, and no clinical or radiologic indication of a non-cerebrovascular mimic, such as a brain metastasis, as the etiology of the deficit(s)
Contraindication to magnetic resonance (MR) imaging, such as implanted metal devices or foreign bodies, severe claustrophobia, or contraindications to contrast agent administration
Immediate need for magnetic resonance imaging (MRI)
Participant had a breast magnetic resonance imaging (MRI) that was performed after the diagnosis of ADH but before surgical excision.
Participants with non- magnetic resonance (MR) compatible objects or implants that would make MRI a contraindication
Screening contrast-enhanced magnetic resonance imaging (MRI) or 99mTc-sestamibi based imaging of the breast(s) within the prior 12 months or planned within the next two years
Patients who are thought to have a breast magnetic resonance imaging (MRI) within 1 year prior to the study
Arm 2 patients must have lymph node, soft tissue, or visceral metastatic disease measuring >= 1 cm, or bone metastases, documented by prior CT or magnetic resonance imaging (MRI) imaging; Arm 2 patients may have hormone-sensitive or castrate-resistant disease and may be receiving treatment with hormonal or other therapies
Previous CT scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP) or EUS of the abdomen in the past three years
Serious medical illness unsuitable for the magnetic resonance (MR) scanner based on best clinical judgment
Must have a negative mammogram or negative breast magnetic resonance imaging (MRI) within 1 year of protocol-required baseline core biopsy\r\n* Patients positive for BRCA mutations must have a negative breast MRI within 1 year of protocol-required baseline core biopsy
Patients with breast implants are usually permitted to have an magnetic resonance imaging (MRI); check with the MRI technician to confirm
Patients must have measurable, supratentorial contrast-enhancing progressive or recurrent glioblastoma or gliosarcoma by magnetic resonance imaging (MRI) imaging within 21 days of starting treatment; patient must be able to tolerate MRIs
Histologically proven diagnosis of solid tumor malignancy and Magnetic Resonance (MR) imaging documenting brain lesions.
More than 1 focal lesion >=5 millimeter (mm) in diameter by magnetic resonance imaging (MRI)
Patients must have a biopsy marker placed within the tumor bed with imaging confirmation (preferably mammogram but ultrasound or magnetic resonance imaging [MRI] is acceptable) of marker placement prior to neoadjuvant chemotherapy
Clinical stage I grade 1-2 endometrial cancer also eligible with deep myoinvasion >= 50% shown on preoperative (preop) magnetic resonance imaging (MRI) and/or elevated preop cancer antigen (CA)-125 > 35 U/ml
Patients with no contra-indications to magnetic resonance (MR) imaging
Patient is not able to undergo magnetic resonance (MR) imaging due to any contraindication to MRI based on departmental MR questionnaire (e.g. past gadolinium allergies, failure of metallic screening, claustrophobia, inability to lay flat for duration of the study, inability to hold breath, etc.)
Diagnostic CT or magnetic resonance imaging (MRI) scan within 2 months of study entry
No contra-indications to magnetic resonance imaging (MRI), including permanent pacemaker, implantable device, aneurysm clip, or severe claustrophobia (for patients planning to be imaged on PET/magnetic resonance [MR] scanner)
Patients who have presence of a known contradiction to MRI\r\n* Pacemaker\r\n* Aneurysm clips\r\n* Patients with implants that are contradicted for magnetic resonance (MR) imaging will be excluded\r\n* Pregnant\r\n* Age and mental status wherein he/she is unable to cooperate for MRI study
Patient agrees to undergo, prior to the procedure, magnetic resonance imaging (MRI, within 14 days and preferably with 3 days of the planned procedure) with perfusion, diffusion and spectroscopic imaging.
Be able to undergo magnetic resonance (MR) imaging
Any contraindication to the use of contrast and/or general guidelines for magnetic resonance (MR) imaging as per standard Department of Radiology imaging guidelines
Contraindication for magnetic resonance imaging
Patient must have a solid tumor with a short-axis greater than or equal to 1 cm (by CT, magnetic resonance imaging (MRI), ultrasonography or mammography) to allow reliable PET imaging.
Patients must be able to tolerate magnetic resonance (MR) imaging required by protocol
Implanted devices, metallic hazards or other conditions presenting a contraindication to 3Tesla cardiac magnetic resonance imaging (MRI)
Diagnostic CT or magnetic resonance imaging (MRI) performed within 30 days prior to the 68Ga-RM2 PET
Contraindication to magnetic resonance imaging (MRI).
Contraindication to magnetic resonance (MRI) imaging, as determined through review of the University of California, San Francisco (UCSF) MRI screening form by study investigator
Scheduled for magnetic resonance imaging (MRI) fusion/transrectal ultrasound (TRUS) biopsy, followed by histology
At least 2 metastatic soft tissue or osseous lesions identified on conventional imaging (CT, magnetic resonance imaging [MRI] or bone scan)
Standard gadolinium-enhanced magnetic resonance imaging (MRI) changes that are considered indeterminate for tumor progression versus (vs.) treatment-related changes by the neuroradiologist or clinician within 24 weeks of completion of radiation
Patients with non-magnetic resonance imaging (MRI) compatible implanted metallic foreign bodies are excluded from this study
Patients whose lung tumors are being monitored by magnetic resonance (MR) imaging as part of standard clinical care
Diagnosis of HCC with one or more of the following:\r\n* Liver mass (>= 1 cm) with arterial phase contrast enhancement and early washout on subsequent phases by CT or magnetic resonance imaging (MRI)\r\n* Suggestive imaging findings plus alpha-feto protein (AFP) > 200 mg/dL; or\r\n* Tumor confirmed by arteriography
Allergy or relative contraindications to magnetic resonance imaging (MRI) contrast agents
Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week
No contraindications to magnetic resonance imaging (MRI)
Suspected first recurrence of a glioblastoma tumor by clinical measures and/or magnetic resonance imaging (MRI)
Patients with a known diagnosis of central nervous system (CNS) malignancy, including metastases, with known enhancement on magnetic resonance (MR) who are otherwise eligible to undergo MRI
Adult patients who require monitored anesthesia for magnetic resonance imaging (MRI) scanning
Magnetic resonance imaging (MRI) or transrectal doppler ultrasound demonstrating at least one target lesion
Presence of a genetic disorder other than NF1 that effects cognition or is associated with magnetic resonance (MR) imaging abnormalities (e.g. tuberous sclerosis)
CT/magnetic resonance imaging (MRI) scan must be obtained within 4 weeks prior to study entry
Patients with reoccurrence of brain tumor\r\n* The principal investigator or co-principal investigator (PI) must review magnetic resonance imaging (MRI) and CT findings based on the radiologic assessment provided they meet the following imaging criteria (as established in the clinical trial 09-177) OR
Any contraindication to baseline MRI based on departmental magnetic resonance (MR) questionnaire, or inability to cooperate for an MRI scan
Inability to undergo a magnetic resonance imaging (MRI) or PET scan (e.g., claustrophobia or metal implant)
Patient must not have any contra-indications to MRI imaging including implanted medical devices and metal objects which may be adversely affected by MRI imaging; all subjects will be required to complete a standard MRI screening form prior to imaging
Able to tolerate magnetic resonance (MR) imaging required by protocol, to be performed at an American College of Radiology Imaging Network (ACRIN)-qualified facility and scanner
Previous MRI imaging of the prostate
The subject has concordant magnetic resonance imaging (MRI)/1H MRSI findings from a magnetic resonance (MR) staging exam at UCSF performed prior to the 13C MRSI exam performed in this study with investigational medicinal product (IMP), or is willing to undergo MRI/1H MRSI in connection with the study exam
Diagnostic quality abdominal imaging (CT or magnetic resonance imaging [MRI]) within the past 45 days
Unable to receive or tolerate magnetic resonance imaging (MRI) scan after evaluation of MRI screening form
Inability to undergo magnetic resonance imaging (i.e. those patients with automated implantable cardioverter defibrillators [AICD]/pacemakers)
Participants requiring conscious sedation for magnetic resonance (MR) imaging
Expected to undergo magnetic resonance imaging (MRI) within two weeks following the study procedure
DCIS must be >= 1 cm based on extent of calcifications, presence of a mass on ultrasound OR enhancement on magnetic resonance imaging (MRI) OR
Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to randomization. Applicable only to metastasectomy participants
Progressive Brain Metastases Cohort\r\n* S1416 is one study with two cohorts; patients who have progressive brain metastases after surgical excision and/or intracranial radiation will be in the Progressive Brain Metastases Cohort and will require a baseline magnetic resonance imaging (MRI); patients with previously treated brain metastases, stable disease and stable neurologic function for 14 days prior to trial registration will be in the Standard Cohort and may obtain MRI of the brain at the physician’s discretion; randomization and treatment is the same for both cohorts\r\n* In addition to all of the previous eligibility criteria, patients with progressive brain metastases who do not satisfy the conditions to enroll in the standard cohort (neurologic stability for 14 days following surgery and/or radiation therapy) must also meet the following criteria to enroll as part of the brain metastases cohort:\r\n** Patients with progressive brain metastases must have a baseline brain MRI within 28 days prior to registration; brain metastases must be progressive and >= 10 mm in longest dimension on radiographic imaging AFTER prior intracranial radiation (IR) therapy (i.e., whol brain radiation therapy [WBRT], stereotactic radiosurgery [SRS], gamma knife [GK] or local equivalent); patients must not have evidence of diffuse leptomeningeal disease on brain MRI or by previously documented cerebrospinal fluid (CSF) cytology; discrete dural metastases are permitted; there must be no evidence of hemorrhage or impending herniation on baseline brain imaging; patients with contraindication to gadolinium-enhanced MRI imaging are not eligible\r\n** Patients must be on a stable or decreasing dose of steroids for >= 7 days prior to registration\r\n** If patient had an open brain biopsy, at least 28 days must have elapsed between biopsy and registration\r\n** Patients enrolling in the Progressive Brain Metastases Cohort can have received up to 3 prior lines of cytotoxic chemotherapy for metastatic disease; note that for enrollment in the standard cohort, patients must have had =< 1 prior cytotoxic regimen for metastatic disease
Participants with known brain metastases may be enrolled in this study if radiation therapy and/or surgery have been completed with a minimum of 3 months of stable disease demonstrated on serial evaluation by computed tomography (CT) (with contrast enhancement) or magnetic resonance imaging (MRI); such participants must no longer require treatment with corticosteroids or enzyme inducing anti-epileptic medications for their central nervous system (CNS) disease
Brain metastasis, unless previously treated with surgery or stereotactic radiosurgery and the disease has been confirmed stable (i.e., no increase in lesion size) for at least 6 weeks with two consecutive magnetic resonance imaging (MRI) scans using contrast prior to study day 1; enzyme inducing anticonvulsants are not allowed while patients are on study treatment
Brain magnetic resonance imaging (MRI) with gadolinium within 4 weeks of study enrollment demonstrating the absence of brain metastases; if an MRI is medically contraindicated or if the patient refuses, a head CT with IV contrast is acceptable
1 inoperable brain metastasis or 2- 10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to the following criteria:
The participant has active brain metastases or epidural disease; participants with brain metastases previously treated with whole brain radiation or radiosurgery or participants with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 4 weeks before starting study treatment are eligible; participants with treated brain metastasis should not take enzyme-inducing anticonvulsive therapies (EIACDs) within 2 weeks of registration, though non-enzyme inducing anticonvulsive drugs such as levetiracetam are allowed; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; baseline brain imaging with contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scans for participants with known brain metastases is required to confirm eligibility
Patients must be free of active brain metastases by contrast-enhanced computerized tomography (CT)/magnetic resonance imaging (MRI) scans within 4 weeks prior to starting the study drugs; if known to have prior brain metastases, must not have evidence of active (enlarging and/or symptomatic lesions) brain disease on two successive MRI evaluations at least 4 weeks apart (one of which is at least 4 weeks prior to starting the study drugs)
Patients with known central nervous system metastases may be enrolled if they have received radiotherapy, do not require chronic steroid therapy, have had computed tomography or magnetic resonance imaging of the brain within 1 month of study entry that shows stable disease and they have no neurological symptoms other than low grade neuropathy.
Patients must have active brain metastases from NSCLC, confirmed by Gadolinium-enhanced MRI without concomitant leptomeningeal carcinomatosis. Dose of steroids must be stable for 5 days before the baseline brain MRI. Patients in Arm 5 must also meet the following inclusion criteria:
Patients must have a brain magnetic resonance imaging (MRI) that is free of active metastases; metastases that have been treated with radiation or surgical resection, are stable for at least 4 weeks and do not require steroids are eligible
Active brain metastases or leptomeningeal disease. Previously treated brain metastases are allowed provided lesions are stable for at least 3 months as documented by head CT scan or magnetic resonance imaging (MRI) of the brain. Patients must be off steroids, but anti-convulsants are allowed.
Brain MRI completed within 6 weeks of Screening.
Patients with known brain metastases or leptomeningeal carcinomatosis will be excluded from this clinical trial. Patients with suspected brain metastases at screening should have an magnetic resonance imaging (MRI) (preferred) or computed tomography (CT) each preferably with intravenous (IV) contrast of the brain prior to study entry.
A diagnostic magnetic resonance imaging (MRI) brain or computed tomography (CT) head demonstrating the presence of 1-4 solid tumor brain metastases and lesion to be resected no more than 5 cm in any direction, performed within 30 days prior to stereotactic radiosurgery. If multiple lesions are present, then the total brain metastases volume can be no more than 30 cm^3 excluding the lesion to be resected
Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans are excluded from this clinical trial; while screening brain MRI is not required, it should be performed if clinically indicated at the discretion of the treating investigator; should patient found to have brain metastasis, treatment of brain metastasis must precede the participation in this study
Patients with evidence of symptomatic brain metastases. Patients with treated (surgically excised or irradiated) and stable brain metastases are eligible assuming the patient has adequately recovered from treatment, the treatment was at least 28 days prior to initiation of study drug, and baseline brain computed tomography (CT) with contrast, or magnetic resonance imaging (MRI) within 14 days of initiation of study drug, is negative for new or worsening brain metastases
Patients with no history of CNS disease will not require a repeat MRI brain unless they have symptoms to suggest new brain metastases
Patients must be free of active brain metastases by contrast-enhanced CT/magnetic resonance imaging (MRI) scans within 4 weeks prior to starting the study drugs; if known to have prior brain metastases, must not have evidence of active (enlarging and/or symptomatic lesions) brain disease on MRI evaluation within 2 weeks from stereotactic radiosurgery (SRS) or whole brain radiation therapy (WBRT) treatment
Subjects with brain metastases must have completed treatment, either surgery or radiation, 4 weeks or longer prior to screening. A brain magnetic resonance imaging (MRI) demonstrating there is no current evidence of progressive brain metastases is required in subjects with previous brain metastasis. Patients with breast tissue expanders may have brain computerized tomography (CT) for assessment.
Brain metastases or spinal cord compression are NOT permitted unless they have been treated with the patient's condition being stable clinically and radiologically for at least 28 calendar days and off steroids for at least 14 calendar days prior to the start of study treatment; patients with suspected or known brain metastases at screening should have a magnetic resonance imaging (MRI) (preferred) or CT brain/head, preferably with IV contrast, to assess baseline disease status
Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study; patients with a history of brain metastases must have a head computed tomography (CT) or magnetic resonance imaging (MRI) scan with contrast to document stable disease for at least 24 weeks prior to enrollment in the study
All subjects must have at least 2 distinct lesions as documented by a complete physical examination and imaging studies within 4 weeks prior to randomization; imaging studies must include a CT scan of the involved disease sites and all known sites of resected disease and brain magnetic resonance (MRI) or CT (brain CT allowable if MRI is contraindicated or if there is no known history of resected brain lesions)
Known active metastases to the brain, spinal cord or leptomeninges unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks of first study treatment as documented by magnetic resonance imaging (MRI) or computerized tomography (CT) imaging and having no ongoing requirement for steroids
Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should be excluded from this clinical trial; screening brain MRI (or CT if MRI contraindicated) will be required for patients with recurrent NSCLC, TNBC, or SCLC; brain MRI (or CT if MRI contraindicated) is required for PDAC if clinically suspected by patient’s symptoms or neurological exam; should patient found to have brain metastasis, treatment of brain metastasis must precede the participation in this study; for patients with known and treated brain metastases is allowed in this study if they fulfill the following criteria:\r\n* The lesions have improved or remained stable radiographically and clinically for at least 6 weeks after completion of brain irradiation or stereotactic brain radiosurgery and off steroids for at least 6 weeks
Patients with clinically active brain metastases (known or suspected) are excluded unless the brain metastases have been previously treated and are considered stable. Stable brain metastases are defined as no change on CT scan or magnetic resonance imaging (MRI) scan for a minimum of 2 months AND no change in steroid dose for a minimum of 4 weeks, unless change due to intercurrent infection or other acute event
Patients who have undergone a resection for brain metastases will be eligible for participation if they have any residual metastases present on post operative magnetic resonance imaging (MRI) of the brain
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to enrollment as documented by magnetic resonance imaging (MRI) or computed tomography (CT) imaging; treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to enrollment as documented by MRI or CT imaging
Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should not be included on this study; screening imaging to rule out brain metastases is not required for screening, but should be performed prior to study enrollment if clinically indicated; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug
Brain or central nervous system (CNS) metastases \r\n* Exception: Adequately treated brain metastases documented by baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan that have not progressed since previous scans and do not require corticosteroids (except prednisone =< 5 mg/day or equivalent) for management of CNS symptoms; a repeated CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases\r\n* Subjects with leptomeningeal carcinomatosis are not permitted
Patients with brain metastases. However, if radiation therapy and/or surgery has been completed and serial evaluation by CT (with contrast enhancement) or MRI over a minimum of one month demonstrates the disease to be stable and if the patient remains must have no need for treatment with steroids
The subject must have a baseline brain magnetic resonance imaging (MRI) scan or CT scan of the head (in patients unable to obtain an MRI) within 14 days prior to first dose of cabozantinib\r\n* Patients receiving glucocorticoids must be on a stable dose of glucocorticoids during the 5 days prior to the baseline brain imaging
Patients with known brain metastases should be excluded from this clinical trial; exception: patients with brain metastases will be allowed on study if they have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of central nervous system (CNS) disease progression as determined by computed tomography (CT) or magnetic resonance imaging (MRI) within 21 days prior to the first dose of study drug
Patients must be able to have MRI brain imaging
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 28 days prior to registration; (contrast enhanced brain computed tomography [CT] is allowed if MRI is contraindicated)
Patient with treated (surgically excised or irradiated) and stable brain metastases are eligible as long as the treatment was at least 4 weeks prior to initiation of study drug and baseline brain computed tomography (CT) with contrast or magnetic resonance imaging (MRI) within 2 weeks of initiation of study drug is negative for new brain metastases. Subjects with stable brain metastases must not require therapy with corticosteroids
Patients with untreated brain metastases are excluded. However, patients with metastatic central nervous system (CNS) tumors may participate in this trial, if the patient is > 4 weeks from therapy completion (including [incl.] radiation and/or surgery), is clinically stable at the time of study entry and is receiving a stable or decreasing dose of corticosteroid therapy; brain magnetic resonance imaging (MRI) or head computed tomography (CT) is required at screening for patients with known brain metastases
Greater than 3 presumed melanoma brain metastases on contrast-enhanced brain MRI scan obtained no greater than 4 weeks prior to study registration
lesions assessed by follow-up scan (or MRI if MRI performed before brain therapy) ? 1 month after brain therapy are considered under control at baseline
Clinically active known brain metastasis unless the brain metastases have been previously treated and are considered stable. Stable brain metastases are defined as no change on computed tomography (CT) scan or magnetic resonance imaging (MRI) for a minimum of 2 months and no change in steroid dose for a minimum of 4 weeks prior to starting the trial.
Patients must have measurable disease in the brain, defined as at least one lesion that can be accurately measured in at least one dimension as >= 10 mm by brain magnetic resonance imaging (MRI); MRI of the brain (with and without gadolinium enhancement) is to be performed using standard 5-mm slices with 2.5-mm spacing for comparison to subsequent MRI scans
Participants with previous brain metastases are eligible provided that they are treated and asymptomatic not requiring steroids or anticonvulsants, and have stable disease at the screening tumor assessment; a 4 week disease stable interval as confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) brain w/ contrast is required after treatment of brain metastases before initiation of thoracic radiation therapy; in addition, subjects must have been either off corticosteroids, or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent)
Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug
Patients must have a brain magnetic resonance imaging (MRI) or computed tomography (CT) (with and without contrast) that is free of active metastases; metastases that have been treated with radiation or surgical resection, are stable for at least 4 weeks and do not require steroids are eligible
Pretreatment brain CT with contrast or brain magnetic resonance imaging (MRI) to rule out metastases
Patients must be free of brain metastasis by contrast-enhanced computed tomography (CT)/magnetic resonance imaging (MRI) scans within 4 weeks prior to enrollment; if known to have prior brain metastases, must not have evidence of active brain disease after definitive therapy (surgery, radiation therapy or stereotactic radiosurgery) on two successive MRI evaluations at least 3 months apart (one of which is =< 4 weeks prior to starting the study drugs)
CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration
Exception: Adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone ? 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.
All patients must have a CT or magnetic resonance imaging (MRI) of the brain within 90 days prior to registration; the brain CT or MRI should be performed with intravenous contrast (unless contraindicated)
Patients with known active brain metastases should be excluded from this clinical trial; patients with prior treated brain metastases are allowed, providing that they were not accompanied by seizures and that a baseline brain magnetic resonance imaging (MRI) scan prior to study entry demonstrates no current evidence of brain metastases; all patients with central nervous system (CNS) metastases must be stable for > 3 months after treatment and off steroid treatment prior to study enrollment
Magnetic resonance imaging (MRI) or CT scans of brain if there are symptoms or signs suggesting brain metastases, must be done within 10 weeks prior to study entry
Evidence of recent hemorrhage on baseline MRI of the brain with the following exceptions:
Patients with spinal cord compression, carcinomatous meningitis, or leptomeningeal disease are excluded; patients with a history of prior brain metastasis are permitted provided the lesions are fully treated, inactive, and patient is asymptomatic; subjects with new evidence of brain metastasis discovered during screening are allowed as long as the brain lesions have been irradiated; lesions must be stable as evidenced by repeat magnetic resonance imaging (MRI) brain imaging within 2 weeks prior to starting study treatment; patients must also be asymptomatic; patient must have had no steroids use for at least 28 days prior to start of treatment; centrally located tumors with radiographic evidence (computed tomography [CT] or MRI) of local invasion of major blood vessels
The subject has active brain metastases or epidural disease (Note: subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; (baseline brain imaging with contrast-enhanced CT or magnetic resonance imaging [MRI] scans for subjects with known brain metastases is required to confirm eligibility)
Patients with known or suspected brain metastases; however, if radiation therapy and/or surgery has been completed and serial evaluation by computed tomography (CT) (with contrast enhancement) or magnetic resonance imaging (MRI) over a minimum of 3 months demonstrates the disease to be stable and if the patient remains asymptomatic, then the patient may be enrolled; such patients must have no need for treatment with steroids or anti-epileptic medications
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to enrollment as documented by magnetic resonance imaging (MRI) or computed tomography (CT) imaging; treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to enrollment as documented by MRI or CT imaging
Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans are ineligible; screening imaging to rule out brain metastases is not required for screening, but should be performed prior to study enrollment if clinically indicated; patients with treated brain metastases must demonstrate stable post-therapeutic imaging and resolution of any associated symptoms and must be stably off steroids with no symptoms for at least 6 months following therapy prior to starting study drug
Brain metastases per magnetic resonance imaging (MRI) or computed tomography (CT)\r\n* Note: patients who have had therapy for brain metastasis (i.e., surgical resection, whole brain radiation, or stereotactic radiosurgery [SRS] even if stable) are not eligible
The subject has active brain metastases or epidural disease (Note: Subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible); neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment (Baseline brain imaging with contrast-enhanced CT or magnetic resonance imaging [MRI] scans for subjects with known brain metastases is required to confirm eligibility)
at least 3 weeks without new brain metastases as evidenced by MRI/CT
Brain metastases are excluded unless: \r\n* All known lesions were previously treated with surgery or stereotactic surgery (whole-brain radiation is not allowed unless given after definitive treatment with surgery or stereotactic surgery), AND \r\n* Brain lesion(s), if still present, must be confirmed stable (i.e., no increase in lesion size) for >= 12 weeks prior to D1 of study treatment (stability must be confirmed with two consecutive magnetic resonance image [MRI] or computed tomography [CT] scans with contrast, AND \r\n* Asymptomatic with no corticosteroid requirements for >= 4 weeks prior to D1 of study treatment, AND \r\n* Treatment with any cytochrome P450 (CYP) enzyme inducing anticonvulsants occurred < 4 weeks prior to D1 of study treatment \r\nNOTE: if study subject has history of brain metastasis, but currently has no evidence of disease in brain (NED), confirmation by two consecutive scans separated by >= 6 weeks prior to D1 of treatment is required
Patient with central nervous system (CNS) metastasis are required to have stable disease documented by being off treatment (surgery, radiation therapy) for at least 2 weeks, and four (4) weeks is preferred; a contrast enhanced brain computed tomography (CT) or brain magnetic resonance imaging (MRI) is required within 35 days of enrollment; patients with brain metastases who qualify for protocol therapy will be included in Cohort 2 (ineligible for treatment with bevacizumab)
Subjects must be free of known brain metastases by contrast-enhanced computed tomography (CT)/magnetic resonance imaging (MRI) scans or have successfully-treated brain metastases and be asymptomatic for more than 1 month
Absence of brain metastases as confirmed by imaging of the brain by MRI or CT brain with contrast performed at baseline screening
Four or fewer brain metastases (as defined on the pre-operative MRI or CT brain scan) and status post resection of one of the lesions
Any unresected lesions must measure < 3.0 cm in maximal extent on the contrasted MRI or CT brain scan obtained =< 35 days prior to pre-registration; the unresected lesions will be treated with SRS; Note: the metastases size restriction does not apply to the resected brain metastasis; with resected brain metastases only surgical cavity size determines eligibility
Histologically confirmed HER2-positive (immunohistochemistry [IHC] 3+ or fluorescence in situ hybridization [FISH] amplified; by clinical assay on either primary or metastatic tumor) adenocarcinoma of the breast with at least one progressive and/or new metastatic brain lesion (>= 5 mm on radiographic imaging); patients in whom brain metastases (BM) are asymptomatic and detected during routine brain magnetic resonance imaging (MRI) screening per institutional protocols are eligible
Patients with solitary brain metastases previously treated with surgery or stereotactic radiosurgery (+/- whole brain radiation therapy [WBRT]) and currently controlled at the time of study enrollment are also eligible but must have an magnetic resonance imaging (MRI) within 80 days prior to study registration; patients with a history of multiple brain metastases must have an MRI showing no active brain metastases within 80 days prior to study registration
Has no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed ?3 weeks after pre-treatment brain imaging, and
Subjects with known brain metastases and contraindications to undergo contrast MRI imaging of the brain are excluded from the study
Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or MRI scans should not be included on this study; screening imaging to rule out brain metastases is not required for screening, but should be performed prior to study enrollment if clinically indicated; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug
Patients with a history or clinical evidence of brain metastasis must have completed radiation therapy or surgical treatment of brain lesions and have no evidence of central nervous system (CNS) progression for at least eight weeks at the time of registration; patients must not require corticosteroids for treatment of cerebral edema from brain metastases; patients must be evaluated with a head magnetic resonance imaging (MRI) within 4 weeks prior to registration
The participant has active brain metastases or epidural disease; participants with stable brain metastases previously treated with whole brain radiation or radiosurgery or participants with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 4 weeks before starting study treatment are eligible; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; baseline brain imaging with contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scans for participants with known brain metastases is required to confirm eligibility
Patient should undergo brain imaging (CT scan or magnetic resonance imaging [MRI]) to rule out brain metastases
Presence of parenchymal brain metastases; patients with neurological symptoms must have a CT or magnetic resonance imaging (MRI) of the brain showing no metastases within 60 days of enrollment
If patient has a history of brain metastases or leptomeningeal disease, lesions must be stable for at least 3 months (as documented by either head computed tomography [CT] or brain magnetic resonance imaging [MRI])
The subject has active brain metastases or epidural disease; subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; baseline brain imaging with contrast-enhanced CT or magnetic resonance imaging (MRI) scans for subjects with known brain metastases is required to confirm eligibility
Patients with history of brain metastases can be enrolled at a minimum of 2 weeks following the completion of surgery, gamma knife or whole brain radiotherapy; repeat brain magnetic resonance imaging (MRI) not required for eligibility
Patients must be free of active brain metastasis by contrast-enhanced computed tomography/magnetic resonance imaging (CT/MRI) scans within 4 weeks prior to enrollment; if known to have prior brain metastases, these must have been adequately managed with standard of care radiation therapy, stereotactic radiosurgery or surgery prior to registration on the study
Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for >= 2 weeks prior to signing informed consent form; magnetic resonance imaging of the brain (or computed tomography scan w/contrast) is preferred for diagnosis
Patients must be free of active brain metastases by contrast-enhanced computed tomography (CT)/magnetic resonance imaging (MRI) scans within 4 weeks prior to starting the study drugs; if known to have prior brain metastases, must not have evidence of active (enlarging and/or symptomatic lesions) brain disease on two successive MRI evaluations at least 3 months apart (one of which is at least 4 weeks prior to starting the study drugs)
Symptomatic leptomeningeal or brain metastases or spinal cord compression Note: Subjects previously treated for these conditions are eligible if they meet both of the criteria below: (1) have had stable CNS disease for at least 4 weeks after local therapy as assessed by imaging (contrast enhanced magnetic resonance imaging [MRI] or computed tomography [CT]) prior to Day 1, and (2) are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 4 weeks prior to Day 1.
Presence of any brain metastases detected by MRI or CT with i.v. contrast of the brain at screening.
Evidence of recent hemorrhage on baseline MRI of the brain.
Patients must be free of brain metastasis by contrast-enhanced CT/magnetic resonance imaging (MRI) scans within 4 weeks prior to enrollment; if known to have prior brain metastases, must not have evidence of active brain disease after definitive therapy (surgery, radiation therapy, or stereotactic radiosurgery) on two successive MRI evaluations at least 3 months apart (one of which is =< 4 weeks prior to starting the study drugs)
History or evidence of brain metastases on MRI or head CT if MRI is not able to be performed.
Clinical evidence for brain metastases (including carcinomatous meningitis) at baseline (may require imaging assessment, e.g. computed tomography [CT] or magnetic resonance imaging [MRI], for certain patient population), with the exception of those subjects who have previously-treated central nervous system (CNS) metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have had no requirement for steroids or enzyme- inducing anticonvulsants within 6 months prior to study entry
Patients may have brain metastases if all lesions have been treated with stereotactic radiation therapy, craniotomy, or gamma knife therapy with no evidence of progression (demonstrated by identical imaging modality for 2 consecutive assessments/scans [magnetic resonance imaging (MRI) or CT scans], at least 4 weeks apart) and have not required steroids for at least 14 days prior to registration
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to the initiation of study treatment; stability must be confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) imaging and/or treating investigator determination
No definitive evidence of brain metastases on brain computed tomography (CT) scan or brain magnetic resonance imaging (MRI) < 1 month prior to study entry
Brain metastases outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =< 21 days prior to Step 1 registration; an allowed exception, regarding ability to image brain metastases, would be that patients who had undergone radiosurgery or surgical resection and are planning adjuvant WBRT do not have to have visible disease but do need a pre-surgery MRI or computed tomography (CT) scan demonstrating brain metastases; however, the brain metastases could not have been within 5 mm of either hippocampus
Patients must have a magnetic resonance imaging (MRI) or CT brain within 4 weeks prior to study entry to rule out asymptomatic brain metastases
Known active metastases to the brain, spinal cord or leptomeninges unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks of first study treatment as documented by magnetic resonance imaging (MRI) or computed tomography (CT) imaging and having no ongoing requirement for steroids
Radiologic evidence of new and/or progressive brain metastases (>= 10 mm in longest dimension) by MRI imaging of the brain
Has known active parenchymal central nervous system (CNS) metastases that are symptomatic, and/or more than one lesions, and/or their largest diameter is > 5-mm and/or require antiepileptic drugs or corticosteroids; patients with carcinomatous meningitis are also excluded; exceptions are: subjects with previously treated brain metastases provided they are stable (without evidence of progression by imaging) for at least 2 weeks prior to C11-AMT and any neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are not using ongoing steroids for at least 7 days prior to C11-AMT; patients with active (i.e. not treated with stereotactic radiosurgery), single, asymptomatic, up to 5-mm in largest diameter brain metastases (measured either by brain magnetic resonance imaging [MRI] with IV contrast or head CT with IV contrast measured within 2 weeks prior to C11-AMT) are allowed
Patient must have newly diagnosed brain metastases visible on brain magnetic resonance imaging (MRI); a biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic
Patients must have measurable disease that is metastatic or locally advanced and unresectable; imaging used to assess all disease per RECIST 1.1 must have been completed within 28 days prior to step 2 randomization; all disease must be assessed and documented on the Baseline Tumor Assessment Form
Patients must have measurable disease per RECIST 1.1; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; if the only measurable disease is cutaneous or subcutaneous, lesions must be at least 10 mm in greatest dimension and able to be serially recorded using calipers and photographs; tests used to assess non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
Patients must have measurable disease according to the standard RECIST version 1.1\r\n* NOTE: computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess the measurable disease must have been completed with 28 days prior to the study drug initiation
Patients must have measurable disease in the pancreas; computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form
CT scans or MRIs used to assess disease at baseline must be submitted for central review
Patients must have metastatic disease that is measurable; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
Patients must have measurable metastatic disease; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; CT scans or MRIs must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Patients must have measurable or non-measurable metastatic disease; computed tomography (CT) scans or magnetic resonance imagings (MRIs) used to assess all disease must have been completed within 28 days prior to Step 2 Randomization; CT scans or MRIs must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Patients must have measurable disease according to the standard RECIST version 1.1; CT scans or magnetic resonance imaging (MRIs) used to assess the measurable disease must have been completed within 28 days prior to registration
Patients must have measurable disease according to the standard Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, computed tomography (CT) scans or magnetic resonance imagings (MRIs) used to assess the measurable disease must have been completed within 28 days prior to study drug initiation
Patients who are unable to undergo MRI
Definitive T3 disease on MRI
Unable to undergo brain MRI
Unable to undergo brain MRI
Subject who cannot undergo MRI.
Ability to undergo MRI scanning with contrast
Participants who cannot undergo a brain MRI
Inability to undergo MRI and/or contraindication for MRI examinations following the MRI protocol; prosthesis or orthopedic or dental braces that would interfere with volumetric analysis of target PN on MRI
Unable tolerate an MRI, or have a contraindication to MRI
Unable to undergo MRI scan (e.g., pacemaker)
Patients unable to undergo MRI are not eligible.
Unable to undergo MRI of the brain (i.e. pacemaker or any other contraindication for MRIs)
Able to undergo brain MRI with and without contrast
Patients who are unable to obtain MRI
Patient unable to have an MRI of the brain
Ability to undergo MRI evaluation.
Patients unable to undergo MRI of the brain
Unable to undergo MRI of the spine
Inability to undergo brain MRI due to medical or personal reasons.
Patients who are allergic to MRI contrast medium or unable to undergo MRI for any other reason.
Inability to undergo MRI due to personal or medical reasons
Inability to undergo MRI due to personal or medical reasons (Arm B)
Patients must be able to undergo an MRI with contrast
Patients unable to undergo an MRI with contrast
Subject is able to undergo either an MRI or administration of contrast agent for CT
Inability to undergo MRI with and without contrast administration
Contraindication to contrast enhanced MRI (i.e. unable to undergo follow-up imaging)
History of having MRI non-compatible metal (injury- or treatment-related) in the body will be an exclusion criteria specific to the MRI sub-study
The subject is unable to undergo MRI scan (e.g., has pacemaker)
Subjects unable to undergo an MRI with contrast
Patients will be excluded if they are unable to obtain an MRI scan
Any contra-indications to undergo MRI imaging.
Unable to undergo MRI
Pre-operative and post-operative brain magnetic resonance imaging (MRI) with and without contrast must be obtained. The requirement for a post-operative MRI is waived for patients who undergo biopsy only. A spine MRI is not required, but may be obtained if clinically indicated. If the spine MRI is positive, the patient would be considered to have M+ disease (defined as neuraxis dissemination) and would be ineligible
MRI of the brain (or contrast CT scan of the brain if patients are unable to undergo MRI) must be obtained in patients with symptoms suggesting possible central nervous system (CNS) metastatic disease; neuroimaging is recommended but not required in asymptomatic patients
Patients who are unable to undergo MRI
Patients unable to undergo MRI exams.
Inability to undergo MRI evaluation for treatment planning and follow-up
Multi-parametric MRI at University of California, Los Angeles (UCLA) within 6 months of study treatment, demonstrating a\r\n* Region of interest (ROI) of MRI suspicion level 3 or higher \r\n* MRI-calculated prostate volume 25 cc to 100 cc
Unable to undergo imaging by either CT scan or MRI
Contraindication for safe MRI, implants, or other conditions that interfere with imaging required for the study (e.g., pacemaker or non-MRI compatible hip prostheses); Note: subjects with bilateral hip implants are not eligible for the study; subjects with a unilateral hip implant may be eligible assuming the implant is MRI compatible and does not present artifact on MRI in the areas of interest
Unable to undergo MRI of the spine
Ability to have MRI as part of post-implant assessment
Patients unable to undergo an MRI of the brain with contrast.
The subject is unable to undergo MRI scan (eg, has pacemaker)
Inability to undergo MRI
Unwilling or unable to undergo a MRI or CT Scan per study protocol requirements
Inability to undergo MRI due to personal and medical reasons
Patient must be willing and able to undergo MRI as outlined in protocol
Patient must be able to undergo MRI with and without contrast; patients who are unable to undergo MRI are ineligible
Must be able to undergo MRI of abdomen (spleen and liver). Patients who are contra indicated for MRI may be enrolled and evaluated by CT scan at the discretion of the Sponsor.
Able to safely undergo MRI exam and receive mild sedation for the treatment
Patients unable to undergo contrast-enhanced MRI.
Patient willing and able to provide written informed consent, including willingness to undergo both endorectal multiparametric MRI and transrectal MRI-guided biopsy at Oregon Health & Science University (OHSU)
Unable to undergo brain MRI due to medical or personal reasons
Inability to undergo MRI and/or contraindication for MRI examinations following the MRI protocol; prosthesis or orthopedic or dental braces that would interfere with volumetric analysis of target PN on MRI
Inability to undergo MRI evaluation for treatment planning and follow-up
Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium- institutional guidelines should be used to determine if patients are at risk for renal dysfunction); note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia
Ever been told not to get an MRI
MRI-incompatible metal implant\r\n* If a potential participant reports implanted metal objects, which might be affected by MRI magnets, the study personnel or MRI technologist will screen over the phone or in person to determine whether the potential participant would be safe during the MRI scan; a current list of implants compatible with MRI will be consulted
Inability to get brain MRI
Patients scheduled to undergo screening breast MRI with contrast
Women too claustrophobic to undergo MRI
Participant is able to undergo radiographic evaluation with CT or MRI
Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc
Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc
Patient must meet standard MRI guidelines and be able and willing to undergo MRI
Participants who are unable to undergo MRI because of documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure
Patient must meet standard MRI guidelines and be able and willing to undergo MRI
Unable to cooperate for MRI
Subjects must be able to undergo MRI imaging without anesthesia
Patients who are unable to undergo MRI scanning due to exclusion by University Hospitals Case Medical Center (UHCMC) MRI restriction policies as mentioned in the standard UHCMC MRI informed consent form
Inability to undergo or cooperate with an MRI or PET scan (e.g., claustrophobia, metal implant)
Participants must be able to undergo MRI scan
Able to undergo contrast enhanced MRI
MRI is contraindicated based on responses to MRI screening questionnaire
Patients who are too claustrophobic to undergo MRI or PET imaging
Patients must agree to undergo serial multiparametric MRI and MRI-guided biopsy
Patients who are unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips
Patients who are too claustrophobic to undergo MRI or PET imaging
Patients who cannot undergo MRI imaging due to MRI exclusion criteria
Unable to cooperate for MRI and/or radiation therapy planning
Age and mental status wherein he/she is unable to cooperate for MRI study
Patients who are unable to undergo MRI
Patient is unable to have a MRI or transrectal ultrasound
If a breast MRI is advised and there is no contraindication to MRI, a breast MRI and ABUS will performed at KUCC (study Arm 1)
If a breast MRI is not performed, an ABUS exam without MRI will be performed (study Arm 2)
Patients with contraindications to MRI (e.g., pacemaker, claustrophobia, etc.) (MR/TRUS only) ---Patients with renal dysfunction are excluded due to their inability to undergo contrast enhanced MRI
Participant must successfully complete the MRI screening form if receiving an MRI
Patients who are unwilling or unable to undergo MRI including patients with contraindication to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc
Patients unwilling or unable to undergo the ecoil placement or multiparametric MRI exam
Patients who are unable to undergo MRI imaging
Patients need not undergo a baseline MRI prior to enrollment
Patients who have undergone a sedated MRI 5-7 days prior, can be re-sedated for post-ferumoxytol MRI
For patients who choose to undergo MRI imaging, hypersensitivity to MRI IV contrast media not suitable for pre-medication
For patients who choose to undergo MRI imaging, patients who are ineligible for an MRI with contrast based on radiology department screening
Patients whose lung tumors are being monitored with magnetic resonance (MR) imaging (MR imaging of the anchored transponders is safe but yields an image artifact around the anchored transponders)
Patients whose lung tumors are being monitored with MR imaging (MR imaging of the anchored transponders is safe but yields an image artifact around the anchored transponders).