This study will investigate the use of hyperpolarized (HP) carbon-13 (13C) alpha-ketoglutarate (aKG) (HP 13C-aKG) to characterize tumor burden in participants with isocitrate dehydrogenase (IDH) mutant glioma.
PRIMARY OBJECTIVES: I. To define the most appropriate imaging parameters for obtaining hyperpolarized 13C-aKG from participants with IDH mutant glioma. II. To assess the safety and feasibility of hyperpolarized 13C-aKG magnetic resonance (MR) metabolic imaging as a new and unique tool for evaluating tumor burden in participants with IDH mutant glioma. OUTLINE: Participants will be assigned to one of 2 cohorts: COHORT 1: Participants with IDH mutant glioma for sequence development. COHORT 2: Participants with recurrent IDH mutant glioma before receiving surgical resection. This imaging study will involve one MR scan with the administration of HP 13C-aKG and will receive a follow-up phone call within 1-7 days post-study to assess for late adverse events.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
Given intravenously at time of imaging
Magnetic resonance imaging is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body
University of California, San Francisco
San Francisco, California, United States
RECRUITINGMean signal to noise ratio of HP 13C-aKG
Signal-to-noise ratio (SNR) of HP 13C-aKG will be calculated voxel-by-voxel, and within each region of interest (ROI). The parameters considered will be the mean SNR, within these ROIs. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast.
Time frame: Day of imaging (1 day)
Mean signal to noise ratio of oncometabolite 2-hydroxyglutarate (2-HG)
Signal-to-noise ratio (SNR) of HP 13C akG 2HG will be calculated voxel-by-voxel, and within each ROI. The parameters considered will be the mean SNR, the number of voxels with SNR 2HG within the normal brain \> 3.0, the number of voxels with SNR 2HG within the lesion \> 3.0. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast. (2HG production only in the IDH mutant tumors).
Time frame: Day of imaging (1 day)
Mean signal to noise ratio of of glutamate
Signal-to-noise ratio (SNR) of 13C aKG glutamate will be calculated voxel-by-voxel, and within each region of interest. The parameters considered will be the number of voxels with SNR glutamate within the normal brain \> 3.0, the number of voxels with SNR glutamate within the lesion \> 3.0, Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (reduced glutamate within the lesion compared to the normal brain).
Time frame: Day of imaging (1 day)
Median signal to noise ratio of 2HG to aKG
Metabolite ratios (2HG/aKG) will be calculated voxel-by-voxel, and within each ROI. Median, maximum, and sum of ratios will be reported. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (2HG production only in the IDH mutant tumors within the lesion compared to the normal brain).
Time frame: Day of imaging (1 day)
Mean signal to noise ratio of 2HG to glutamate
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Metabolite ratios (2HG/glutamate) will be calculated voxel-by-voxel, and within each ROI. Median, maximum, and sum of ratios will be reported. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (2HG production only in the IDH mutant tumors and reduced glutamate within the lesion compared to the normal brain).
Time frame: Day of imaging (1 day)
Proportion of participants who reported treatment-emergent adverse events
Occurrence of clinically significant changes in safety variables, including injection site, as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported.
Time frame: Day of imaging (1 day)
Comparison of HP 13C 2HG/aKG ratio with surgical results (Cohort 2)
In Cohort 2, the ratio of 13C (2HG/aKG will be compared within normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test
Time frame: Day of imaging (1 day)
Comparison of HP 13C 2HG/glutamate ratio with surgical results (Cohort 2)
In Cohort 2, the ratio of 13C 2HG/glutamate will be compared within a normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test
Time frame: Day of imaging (1 day)
Comparison of HP 13C glutamate/aKG ratio with surgical results (Cohort 2)
In Cohort 2, the ratio of 13C glutamate/aKG will be compared within a normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test
Time frame: Day of imaging (1 day)