Hyperpolarized Imaging in Diagnosing Participants With Glioma

PRIMARY OBJECTIVES:

I. To assess the safety and feasibility of hyperpolarized carbon C 13 (13C) magnetic
resonance (MR) metabolic imaging as a new and unique tool for evaluating tumor burden and
detecting early response to standard therapy in patients with glioma.

II. To define the most appropriate imaging parameters for obtaining hyperpolarized 13C data
from the brain, sixty patients with evidence of residual disease from a prior MRI examination
will be scanned with a slice select magnetic resonance spectroscopic (MRS) sequence, a
dynamic 2dimensional (D) magnetic resonance spectroscopic imaging (MRSI) or a single time
point 3D MRSI sequence after receiving an injection of hyperpolarized 13C pyruvate.

III. To establish the time course of changes in hyperpolarized pyruvate and lactate peaks on
a voxel by voxel basis using dynamic 2D MRSI.

IV. To evaluate if patients who receive treatment with standard radiation and temozolomide
exhibit a reduction in hyperpolarized 13C lactate/pyruvate at post-radiation follow-up
compared to their baseline scan.

OUTLINE: Participants are assigned to 1 of 2 cohorts.

COHORT I: Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo
MRI.

COHORT II: Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before
standard treatment with radiation therapy and temozolomide and 4 weeks after completion of
radiation therapy.

After completion of study treatment, participants are followed for up to 24 months.

Inclusion Criteria:

- FOR PATIENTS IN COHORT 1: Histologically proven glioma who have evidence of evaluable
disease based on a prior MR scan.

- FOR PATIENTS IN COHORT 2: Histologically proven glioma who will be undergoing standard
treatment with radiation and temozolomide.

- A life expectancy > 12 weeks.

- Patients must have a Karnofsky performance status of >= 60.

- White blood cell (WBC) > 3,000/ul within 14 days prior to hyperpolarized imaging scan.

- Absolute neutrophil count (ANC) > 1,500/mm^3 within 14 days prior to hyperpolarized
imaging scan.

- Platelet count of > 100,000/mm^3 within 14 days prior to hyperpolarized imaging scan.

- Hemoglobin > 10 mg/dl within 14 days prior to hyperpolarized imaging scan.

- Serum glutamic-oxaloacetic transaminase (SGOT) < 1.5 times upper limit of normal (ULN)
within 14 days prior to hyperpolarized imaging scan.

- Bilirubin < 1.5 times ULN within 14 days prior to hyperpolarized imaging scan.

- Creatinine < 1.5 mg/dL within 14 days prior to hyperpolarized imaging scan.

- Patients must not have any significant medical illnesses that in the investigator's
opinion cannot be adequately controlled with appropriate therapy, would compromise the
patient's ability to tolerate the imaging examination or any disease that will obscure
toxicity or dangerously alter response to the imaging agent.

- Patients must not have New York Heart Association (NYHA) grade II or greater
congestive heart failure.

- Patients must not have a history of myocardial infarction or unstable angina within 12
months prior to study enrollment.

- Patients must sign an informed consent indicating that they are aware of the
investigational nature of this study. Patients must sign an authorization for the
release of their protected health information.

- Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV
testing is not required for study participation.

- Patients must not have a history of any other cancer (except non-melanoma skin cancer
or carcinoma in-situ of the cervix), unless in complete remission and off of all
therapy for that disease for a minimum of 3 years.

- Patients must not be pregnant or breast feeding. Women of childbearing potential are
required to obtain a negative pregnancy test within 14 days of hyperpolarized imaging
scan. Effective contraception (men and women) must be used in subjects of
child-bearing potential.

Exclusion Criteria:

- Subjects must be excluded from participating in this study if they are not able to
comply with study and/or follow-up procedures.