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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-03744 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) | |
| 5P01CA118816-12 | U.S. NIH Grant/Contract | View source | |
| 2P50CA097257 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG) | Experimental | Cohort 1 will be comprised of 10 participants with Isocitrate dehydrogenase (IDH) mutant glioma who may or may not have received prior treatment for optimizing imaging protocol. Participants will be injected with 0.67ml/kg actual body weight of 100 millimolar (mM) of α-KG solution and have a single imaging scan. | |
| Cohort 2: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG) | Experimental | Cohort 2 will be comprised 30 participants with recurrent IDH mutant glioma before receiving surgical resection. Participants will be injected with 0.67ml/kg actual body weight of 100 millimolar (mM) of α-KG solution and have a single imaging scan. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG) | Drug | Given intravenously at time of imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean 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. | 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). | 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). | 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). | Day of imaging (1 day) |
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Inclusion Criteria:
1. Participants must be > 18 years old who have evidence of evaluable disease (with contrast enhancing lesion or non-enhancing lesion > 1 cubic centimetre (cc))
All the subjects must have prior MR scans available for review to assess the location and size of residual/recurrent tumor and do not have contraindication for magnetic resonance (MR) examinations. To be included in the study all subjects must also meet the following criteria:
Exclusion Criteria:
1. Participants are excluded from participating in this study if they are not able to comply with study procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Susan Chang, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2024 | Dec 27, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Magnetic Resonance Image (MRI) | Procedure | Magnetic resonance imaging is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body |
|
| Mean signal to noise ratio of 2HG to glutamate | 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). | 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. | 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 | 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 | 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 | Day of imaging (1 day) |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |