Clinical trial NCT05851378: Hyperpolarized Carbon-13 Alpha-ketoglutarate Imaging in IDH Mutant Glioma
Official title: Hyperpolarized Carbon-13 Alpha-ketoglutarate Metabolic Imaging in IDH Mutant Glioma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Adult Gliomas, Mixed
Keywords: Isocitrate Dehydrogenase Mutation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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 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.

Primary outcomes:
measure: Mean signal to noise ratio of HP 13C-aKG
timeFrame: Day of imaging (1 day)
measure: Mean signal to noise ratio of oncometabolite 2-hydroxyglutarate (2-HG)
timeFrame: Day of imaging (1 day)
measure: Mean signal to noise ratio of of glutamate
timeFrame: Day of imaging (1 day)
measure: Median signal to noise ratio of 2HG to aKG
timeFrame: Day of imaging (1 day)
measure: Mean signal to noise ratio of 2HG to glutamate
timeFrame: Day of imaging (1 day)
measure: Proportion of participants who reported treatment-emergent adverse events
timeFrame: Day of imaging (1 day)
measure: Comparison of HP 13C 2HG/aKG ratio with surgical results (Cohort 2)
timeFrame: Day of imaging (1 day)
measure: Comparison of HP 13C 2HG/glutamate ratio with surgical results (Cohort 2)
timeFrame: Day of imaging (1 day)
measure: Comparison of HP 13C glutamate/aKG ratio with surgical results (Cohort 2)
timeFrame: Day of imaging (1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Susan Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: