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Hyperpolarized Carbon-13 Alpha-ketoglutarate Imaging in IDH Mutant Glioma | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

Hyperpolarized Carbon-13 Alpha-ketoglutarate Imaging in IDH Mutant Glioma

Hyperpolarized Carbon-13 Alpha-ketoglutarate Metabolic Imaging in IDH Mutant Glioma

NCT05851378•Robert Bok, MD, PhD

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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))
•Cohort 1: Participants with IDH mutant glioma who may or may not have received prior treatment
•Cohort 2: Participants with recurrent IDH mutant glioma before receiving surgical resection,
•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:
•1. Participants must have a life expectancy \> 8 weeks.
•2. Participants must have a Karnofsky performance status of \> 70.
•3. Participants must have adequate renal function (creatinine \< 1.5 mg/dL). This test must be performed within 60 days prior to the HP 13C Imaging scan.
•4. Participants must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the participant's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
•5. Participants must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure.
•6. Participants must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
+5 more criteria

Exclusion Criteria

•1\. Participants are excluded from participating in this study if they are not able to comply with study procedures.

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Key Dates

Start Date

April 11, 2023

Primary Completion Date

April 30, 2027

Completion Date

April 30, 2027

Last Updated

January 12, 2026

Enrollment

ESTIMATED participants

Conditions

Adult Gliomas, Mixed

Interventions

Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG)

DRUG

Magnetic Resonance Image (MRI)

PROCEDURE

Contacts

Wendy Ma

CONTACT

(415) 514-4418 Wendy.Ma@ucsf.edu