Recruiting
Phase 1

Hyperpolarized C 13 Pyruvate

Sponsor:

Susan Chang

Code:

NCT03739411

Conditions

Glioma

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized Carbon C 13 Pyruvate

Magnetic Resonance Imaging

Radiation Therapy

Chemotherapy

Study Details

Brief summary:

This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.

Conditions

Glioma

Study ID

NCT03739411

Start date

Dec 9, 2015

Status verified date

Jun, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

For Participants in Cohort 1: Suspected or histologically proven glioma who have evidence of evaluable disease based on a prior magnetic resonance (MR) scan.

For Participants in Cohort 2: Histologically proven glioma who will be undergoing treatment.

To be included in the study all subjects must also meet the following criteria:

1. Participants must be > 18 years old and with a life expectancy > 12 weeks.
2. Participants must have a Karnofsky performance status of ≥ 60.
3. Participants must have adequate renal function (creatinine < 1.5 mg/dL) before starting therapy. This tests must be performed within 60 days prior to Hyperpolarized 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 patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter 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 a 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. Patients must sign an authorization for the release of their protected health information.
9. Participants may not be known to be human immunodeficiency virus (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 in complete remission and 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 child-bearing potential.

Exclusion Criteria:

1\. Participants must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort I (Hyperpolarized C13, MRI)

Participants receive hyperpolarized carbon C 13 pyruvate intravenously IV and undergo MRI. The second hyperpolarized 13 C injection/imaging will be started approximately 15 to 60 minutes after the first injection for those who are willing to receive two 13 C injections

experimental: Cohort II (Hyperpolarized C13, MRI)

Participants receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before treatment and 4 weeks after completion of cancer therapy given outside of this study.

Interventions

Hyperpolarized Carbon C 13 Pyruvate

Given IV

Magnetic Resonance Imaging

Undergo MRI

Radiation Therapy

Undergo radiation therapy for cancer outside of this study.

Chemotherapy

Undergo chemotherapy for cancer outside of this study.

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Up to 24 months ]
  • Peak lactate/pyruvate ratio in brain tissue [ Time Frame: Up to 24 months ]
  • Peak lactate/pyruvate ratio in (13C) pyruvate scan [ Time Frame: Up to 4 months. ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Susan M. Chang, MD

More Information

Sponsor

Susan Chang

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Susan Chang on 2026-06-18.