Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma

PRIMARY OBJECTIVES: I. To evaluation safety of hyperpolarized (HP) pyruvate (13C) injection for use in imaging lesions in participants with glioblastoma (GBM). II. To evaluate metabolic changes in tumors and normal-appearing brain tissue in response to standard therapy. EXPLORATORY OBJECTIVES: I. To evaluate changes in 13C parameters from baseline to the post-RT scan compared in the normal appearing brain, enhancing lesion, non-enhancing lesion and the choline-to-N -acetyl aspartate (NAA) index (CNI) lesion. II. To evaluate 13C metabolic parameters from the recurrent lesions compared to those in the regions of treatment related effects. III. To evaluate 13C and 1H metabolic parameters to determine the association to time to progression and overall survival. OUTLINE: Participants are assigned to 3 cohorts based on disease status and non-investigational treatment plan. All participants enrolled in the study will receive at least 1 hyperpolarized pyruvate (13C) injection. COHORT 1: Participants with newly diagnosed glioblastoma who will undergo standard of treatment with radiotherapy and temozolomide (TMZ). Magnetic resonance spectroscopic imaging (MRSI) imaging will occur at 2 time points: Before receiving non-investigational treatment with radiation and chemotherapy, and at the first post-radiation follow-up scan. Each time point includes a hyperpolarized 13C pyruvate injection for research imaging as well as a standard MR. COHORT 2: Participants with recurrent, suspected GBM who will receive non-investigational surgical resection. MRSI imaging with hyperpolarized 13C pyruvate injection will occur at a single time point before surgery. COHORT 3: Participants with recurrent suspected GBM who will undergo non-investigational standard treatment will have three MR examination time points. Each time point includes a hyperpolarized 13C pyruvate injection for research imaging as well as standard MR. The MR examinations will occur prior to initiating therapy (baseline), at approximately 7-14 days after initiation of therapy, and 6-8 weeks after the initiation of therapy. Participants will be follow-up for up to 2 months after completion of non-investigational treatment, and for 7 days after final injection of hyperpolarized 13C.