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Completed

NCT Number: NCT05851378

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

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.

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Key information

Conditions

Adult Gliomas, Mixed Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

  • Participants must have a life expectancy > 8 weeks.
  • Participants must have a Karnofsky performance status of > 70.
  • 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.
  • 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.
  • Participants must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure.
  • Participants must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
  • 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.
  • 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.
  • Participants may not be known to be HIV-positive. HIV testing is not required for study participation.
  • 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.
  • 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

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

Treatment and study plan

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

Drug

Given intravenously at time of imaging

Other names: Hyperpolarized C13-aKG, HP C13-aKG

Magnetic Resonance Image (MRI)

Procedure

Magnetic resonance imaging is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body

Other names: MRI, MRI scan

Primary outcomes

  1. Mean signal to noise ratio of HP 13C-aKG

    Time frame: Day of imaging (1 day)

    Signal-to-noise ratio (SNR) of HP 13C-aKG will be calculated voxel-by-voxel, and within each region of interest (ROI). The parameters considered will be the mean SNR, within these ROIs. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast.

  2. Mean signal to noise ratio of oncometabolite 2-hydroxyglutarate (2-HG)

    Time frame: Day of imaging (1 day)

    Signal-to-noise ratio (SNR) of HP 13C akG 2HG will be calculated voxel-by-voxel, and within each ROI. The parameters considered will be the mean SNR, the number of voxels with SNR 2HG within the normal brain > 3.0, the number of voxels with SNR 2HG within the lesion > 3.0. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast. (2HG production only in the IDH mutant tumors).

  3. Mean signal to noise ratio of of glutamate

    Time frame: Day of imaging (1 day)

    Signal-to-noise ratio (SNR) of 13C aKG glutamate will be calculated voxel-by-voxel, and within each region of interest. The parameters considered will be the number of voxels with SNR glutamate within the normal brain > 3.0, the number of voxels with SNR glutamate within the lesion > 3.0, Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (reduced glutamate within the lesion compared to the normal brain).

  4. Median signal to noise ratio of 2HG to aKG

    Time frame: Day of imaging (1 day)

    Metabolite ratios (2HG/aKG) will be calculated voxel-by-voxel, and within each ROI. Median, maximum, and sum of ratios will be reported. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (2HG production only in the IDH mutant tumors within the lesion compared to the normal brain).

  5. Mean signal to noise ratio of 2HG to glutamate

    Time frame: Day of imaging (1 day)

    Metabolite ratios (2HG/glutamate) will be calculated voxel-by-voxel, and within each ROI. Median, maximum, and sum of ratios will be reported. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (2HG production only in the IDH mutant tumors and reduced glutamate within the lesion compared to the normal brain).

  6. Proportion of participants who reported treatment-emergent adverse events

    Time frame: Day of imaging (1 day)

    Occurrence of clinically significant changes in safety variables, including injection site, as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported.

  7. Comparison of HP 13C 2HG/aKG ratio with surgical results (Cohort 2)

    Time frame: Day of imaging (1 day)

    In Cohort 2, the ratio of 13C (2HG/aKG will be compared within normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test

  8. Comparison of HP 13C 2HG/glutamate ratio with surgical results (Cohort 2)

    Time frame: Day of imaging (1 day)

    In Cohort 2, the ratio of 13C 2HG/glutamate will be compared within a normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test

  9. Comparison of HP 13C glutamate/aKG ratio with surgical results (Cohort 2)

    Time frame: Day of imaging (1 day)

    In Cohort 2, the ratio of 13C glutamate/aKG will be compared within a normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test

Sponsors and collaborators

Lead sponsor

Robert Bok, MD, PhD

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 9, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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