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

Last updated: January 3, 2025
Sponsor: Robert Bok, MD, PhD
Overall Status: Active - Recruiting

Phase

1

Condition

Cancer

Brain Cancer

Brain Tumor

Treatment

Magnetic Resonance Image (MRI)

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

Clinical Study ID

NCT05851378
22925
5P01CA118816-12
NCI-2023-03744
2P50CA097257
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must be > 18 years old who have evidence of evaluable disease (withcontrast enhancing lesion or non-enhancing lesion > 1 cubic centimetre (cc))
  • Cohort 1: Participants with IDH mutant glioma who may or may not have received priortreatment

  • Cohort 2: Participants with recurrent IDH mutant glioma before receiving surgicalresection,

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 testmust be performed within 60 days prior to the HP 13C Imaging scan.

  4. Participants must not have any significant medical illnesses that in theinvestigator's opinion cannot be adequately controlled with appropriate therapy,would compromise the participant's ability to participate in this study or anydisease that will obscure toxicity or dangerously impact response to the imagingagent.

  5. Participants must not have New York Heart Association (NYHA) Grade II or greatercongestive heart failure.

  6. Participants must not have history of myocardial infarction or unstable anginawithin 12 months prior to study enrollment.

  7. This study was designed to include women and minorities but was not designed tomeasure differences of intervention effects. Males and females will be recruitedwith 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 theinvestigational nature of this study. Participants must sign an authorization forthe release of their protected health information.

  9. Participants may not be known to be HIV-positive. HIV testing is not required forstudy participation.

  10. Participants must not have a history of any other cancer (except non-melanoma skincancer or carcinoma in-situ of the cervix), unless they are in complete remissionand 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 potentialare required to obtain a negative pregnancy test within 14 days of HyperpolarizedImaging scan. Effective contraception (men and women) must be used in subjects ofchildbearing potential.

Exclusion

Exclusion Criteria:

  1. Participants are excluded from participating in this study if they are not able tocomply with study procedures.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Magnetic Resonance Image (MRI)
Phase: 1
Study Start date:
April 11, 2023
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

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