This research trial studies how well carbon-11 acetate positron emission tomography (PET)/computed tomography (CT) works in diagnosing participants with glioma. Carbon-11 acetate is an experimental radioactive material which moves through your body after it has been injected into one of your veins. The PET/CT scan may be able to trace the small amount of carbon-11 acetate and reveal areas in your brain that are burning carbon-11 acetate for fuel.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02986815.
PRIMARY OBJECTIVES:
I. To determine whether carbon-11 acetate ([11C]acetate) PET imaging can differentiate glioma from normal brain in patients with grades 2, 3 or 4 gliomas by comparison of visual assessment and standardized uptake value (SUV) with standard clinical magnetic resonance (MR) imaging assessment using T2/fluid-attenuated inversion recovery (FLAIR) and gadolinium enhancement.
SECONDARY OBJECTIVES:
I. To compare uptake of [11C]acetate at baseline among untreated grade 2, grade 3, and grade 4 gliomas.
II. To compare uptake of [11C]acetate at baseline among key molecular glioma subgroups (IDH mutant versus [vs.] wildtype [WT]; 1p/19q co-deleted vs intact; and EGFR amplified vs non-amplified).
III. To determine whether uptake of [11C]acetate is decreased in grade 2 glioma patients following treatment with either an IDH inhibitor or with radiation followed by chemotherapy, compared to the same patient’s pre-treatment [11C]acetate uptake.
IV. To determine whether uptake of [11C]acetate is decreased in grade 3 and 4 glioma patients following treatment with concurrent radiation and temozolomide, compared to their pre-treatment uptake.
V. To determine whether uptake of [11C]acetate is changed from uptake after radiation/temozolomide at the time of tumor progression in treated grade 3 and 4 gliomas.
VI. Percentage of patients that experience adverse events by Common Terminology Criteria for Adverse Events, version 3.0.
OUTLINE:
Participants receive carbon-11 acetate intravenously (IV) then undergo PET/CT scan over 30 minutes at baseline and 2-3 months after treatment.
After completion of study treatment, participants are followed up every 6 months.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorRobert M. Bachoo