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

Trial Title: Hyperpolarized Carbon-13 Alpha-ketoglutarate Imaging in IDH Mutant Glioma

NCT ID: NCT05851378

Condition: Adult Gliomas, Mixed

Conditions: Official terms:
Glioma

Conditions: Keywords:
Isocitrate Dehydrogenase Mutation

Study type: Interventional

Study phase: Early Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG)
Description: Given intravenously at time of imaging
Arm group label: Cohort 1: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)
Arm group label: Cohort 2: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)

Other name: Hyperpolarized C13-aKG

Other name: HP C13-aKG

Intervention type: Procedure
Intervention name: Magnetic Resonance Image (MRI)
Description: Magnetic resonance imaging is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body
Arm group label: Cohort 1: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)
Arm group label: Cohort 2: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)

Other name: MRI

Other name: MRI scan

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).

Criteria for eligibility:
Criteria:
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. 7. This study was designed to include women and minorities but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race. 8. Participants must sign an informed consent indicating that they are aware of the investigational nature of this study. Participants must sign an authorization for the release of their protected health information. 9. Participants may not be known to be HIV-positive. HIV testing is not required for study participation. 10. Participants must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years. 11. Participants must not be pregnant or breast-feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and women) must be used in subjects of childbearing potential. Exclusion Criteria: 1. Participants are excluded from participating in this study if they are not able to comply with study procedures.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of California, San Francisco

Address:
City: San Francisco
Zip: 94143
Country: United States

Status: Recruiting

Contact:
Last name: Wendy Ma

Phone: 415-514-4418
Email: Wendy.Ma@ucsf.edu

Contact backup:

Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Investigator:
Last name: Susan Chang, MD
Email: Principal Investigator

Investigator:
Last name: Daniel Vigneron, PhD
Email: Sub-Investigator

Start date: April 11, 2023

Completion date: April 30, 2026

Lead sponsor:
Agency: Robert Bok, MD, PhD
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of California, San Francisco

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05851378