Precise DCE-MRI in Diagnosing Participants With Recurrent High Grade Glioma or Melanoma Brain Metastases

PRIMARY OBJECTIVES:

I. To optimize and technically validate specially-tailored acquisition and reconstruction
(STAR) DCE-MRI based on the accuracy and reproducibility of whole-brain tracer-kinetic (TK)
parameter maps.

SECONDARY OBJECTIVES:

I. To develop a robust clinical implementation of STAR DCE-MRI. II. To clinically evaluate
STAR DCE-MRI in patients with brain tumors.

OUTLINE: Participants are assigned to 1 of 2 cohorts.

COHORT I: Participants with recurrent high-grade glioma undergo STAR DCE-MRI every 2 months,
and just prior to and 4-6 weeks after starting bevacizumab treatment. If there is concern for
tumor progression (i.e. increased contrast enhancement), more frequent MRI scans will be
scheduled.

COHORT II: Participants with melanoma brain metastases undergo STAR DCE-MRI at baseline and
4-6 weeks after therapy. Participants may undergo more frequent MRI if there is concern for
tumor progression.

Inclusion Criteria:

- COHORT I: Recurrent high-grade glioma (often with thin areas of enhancement) treated
with bevacizumab.

- COHORT I: We will include adult patients with histopathologically confirmed high-grade
glioma with evidence of tumor progression at baseline MRI who will undergo treatment
with an anti-angiogenic agent (bevacizumab) with or without concomitant chemotherapy,
and Karnofsky Performance Score > 60%.

- COHORT I: At least 30 days should have elapsed since prior therapy including surgery
and temozolomide chemoradiation.

- COHORT I: Satisfactory renal, hepatic, and hematologic function is required.

- COHORT II: Melanoma brain metastases (often small and spread throughout the brain)
treated with immunotherapy.

- COHORT II: We will include adult patients with a tissue-proven history of melanoma who
have contrast enhancing brain masses who will undergo treatment with immunotherapy
with an anti-CTLA-4 or anti-PD-1 approach (e.g. ipilimumab, pembrolizumab, or
nivolumab), and Karnofsky Performance Score > 60%.

- COHORT II: At least 30 days should have elapsed since prior therapy including surgery,
stereotactic brain irradiation, and corticosteroid use.

Exclusion Criteria:

- COHORT I: Exclusion criteria include treatment with any other anti-cancer treatment,
enzyme-inducing antiepileptic agents, anticoagulant treatment, pregnancy, other
anti-angiogenesis therapy and prior thrombo-embolic disorders.

- COHORT I: Exclusion criteria will include the standard contraindications for MRI: 1)
prior work as a machinist or metal worker, or history of metal being removed from the
eyes, 2) cardiac pacemaker or internal pacing wires, 3) non-MRI compatible vena cava
filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic
implant, neuro-stimulator unit, ocular implant, or intrauterine device, or 4)
claustrophobia, or uncontrollable motion disorder.

- COHORT I: Pregnant women, prisoners, and institutionalized individuals will be
excluded.

- COHORT II: Exclusion criteria include treatment with any other anti-cancer treatment,
and other immunotherapy exclusion criteria.

- COHORT II: Non-cutaneous melanomas will be excluded.

- COHORT II: Exclusion criteria will include the standard contraindications for MRI: 1)
prior work as a machinist or metal worker, or history of metal being removed from the
eyes, 2) cardiac pacemaker or internal pacing wires, 3) non-MRI compatible vena cava
filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic
implant, neuro-stimulator unit, ocular implant, or intrauterine device, or 4)
claustrophobia, or uncontrollable motion disorder.

- COHORT II: Pregnant women, prisoners, and institutionalized individuals will be
excluded.