Hyperpolarized Imaging in Diagnosing Participants With Glioma

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    140
  • sponsor
    Susan Chang
Updated on 25 January 2021
renal function
cancer
karnofsky performance status
MRI
temozolomide

Summary

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.

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 have hyperpolarized metabolic imaging after receiving one or two injections of hyperpolarized 13 C pyruvate. For subjects who are willing to receive two injections, the 2nd injection will be used to assess reproducibility, evaluate the performance of new acquisition methods, or compare metabolism between [1-13C]pyruvate and [213C]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(s) 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 one or two hyperpolarized carbon C 13 pyruvate injections 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.

Details
Condition Glioma, Gliomas, glial tumor
Treatment radiation therapy, magnetic resonance imaging, Temozolomide, Hyperpolarized Carbon C 13 Pyruvate
Clinical Study IdentifierNCT03739411
SponsorSusan Chang
Last Modified on25 January 2021

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