Last updated on June 2020

Hyperpolarized Imaging in Diagnosing Participants With Glioma


Brief description of study

This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.

Detailed Study Description

PRIMARY OBJECTIVES:

  1. To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for evaluating tumor burden and detecting early response to standard therapy in patients with glioma.
  2. To define the most appropriate imaging parameters for obtaining hyperpolarized 13C data from the brain, one hundred patients with evidence of residual disease from a prior MRI examination will be scanned with either a slice select, a dynamic or a single time point MR sequence after receiving an injection of hyperpolarized 13C pyruvate.
  3. To establish the time course of changes in hyperpolarized pyruvate and lactate peaks on a voxel by voxel basis from the dynamic hyperpolarized data after the injection of hyperpolarized 13C pyruvate. Twenty patients will be studied before and after treatment with standard radiation and temozolomide in order to determine the time course of delivery of 13C pyruvate and the location of maximum pyruvate and lactate or glutamate signals in normal brain and in the region of T2 hyperintensity (T2L).
  4. To evaluate if patients who receive treatment with standard radiation and temozolomide exhibit a reduction in hyperpolarized 13C lactate/pyruvate or 13C glutamate/pyruvate at post-radiation follow-up compared to their baseline scan. A second group of twenty patients will be studied at the time determined from the prior group to provide the maximum contrast between lactate/pyruvate or glutamate/pyruvate in the lesion versus normal brain.

OUTLINE: Participants are assigned to 1 of 2 cohorts.

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

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.

Clinical Study Identifier: NCT03739411

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Recruitment Status: Open


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