Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851378
Status:
RECRUITING
Last Update Posted:
2023-08-24
First Post:
2023-05-01
Brief Title:
Hyperpolarized Carbon-13 Alpha-ketoglutarate Imaging in IDH Mutant Glioma
Sponsor:
Robert Bok MD PhD
Organization:
University of California San Francisco
Study Overview
Official Title:
Hyperpolarized Carbon-13 Alpha-ketoglutarate Metabolic Imaging in IDH Mutant Glioma
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the use of hyperpolarized HP carbon-13 13C alpha-ketoglutarate aKG HP 13C-aKG to characterize tumor burden in patients with isocitrate dehydrogenase IDH mutant glioma
Detailed Description:
PRIMARY OBJECTIVES
I To define the most appropriate imaging parameters for obtaining hyperpolarized 13C-aKG from patients 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 patients with IDH mutant glioma
OUTLINE
This imaging study will involve one MR scan with the administration of HP 13C-aKG Patients will be assigned to one of 2 cohorts Cohort 1 Participants with IDH mutant glioma for sequence development and Cohort 2 Participants with recurrent IDH mutant glioma before receiving surgical resection
I To define the most appropriate imaging parameters for obtaining hyperpolarized 13C-aKG from patients 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 patients with IDH mutant glioma
OUTLINE
This imaging study will involve one MR scan with the administration of HP 13C-aKG Patients will be assigned to one of 2 cohorts Cohort 1 Participants with IDH mutant glioma for sequence development and Cohort 2 Participants with recurrent IDH mutant glioma before receiving surgical resection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2P50CA097257 | NIH | NCI Clinical Trials Reporting Program CTRP | httpsreporternihgovquickSearch2P50CA097257 |
| NCI-2023-03744 | REGISTRY | None | None |
| 5P01CA118816-12 | NIH | None | None |