RecruitingEarly Phase 1

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

United States40 participantsStarted 2023-04-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.

Exclusion criteria

✕. 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.
✕0. 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.
✕1. 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.

What they're measuring

Mean signal to noise ratio of HP 13C-aKG

Timeframe: Day of imaging (1 day)

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

Timeframe: Day of imaging (1 day)

Mean signal to noise ratio of of glutamate

Timeframe: Day of imaging (1 day)

Median signal to noise ratio of 2HG to aKG

Timeframe: Day of imaging (1 day)

Mean signal to noise ratio of 2HG to glutamate

Timeframe: Day of imaging (1 day)

Proportion of participants who reported treatment-emergent adverse events

Timeframe: Day of imaging (1 day)

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

Timeframe: Day of imaging (1 day)

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

Timeframe: Day of imaging (1 day)

Trial details

NCT IDNCT05851378

SponsorRobert Bok, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Wendy Ma

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

View on ClinicalTrials.gov More Adult Gliomas, Mixed trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.

Exclusion criteria

✕. 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.
✕0. 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.
✕1. 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.

What they're measuring

Mean signal to noise ratio of HP 13C-aKG

Timeframe: Day of imaging (1 day)

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

Timeframe: Day of imaging (1 day)

Mean signal to noise ratio of of glutamate

Timeframe: Day of imaging (1 day)

Median signal to noise ratio of 2HG to aKG

Timeframe: Day of imaging (1 day)

Mean signal to noise ratio of 2HG to glutamate

Timeframe: Day of imaging (1 day)

Proportion of participants who reported treatment-emergent adverse events

Timeframe: Day of imaging (1 day)

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

Timeframe: Day of imaging (1 day)

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

Timeframe: Day of imaging (1 day)