Hyperpolarized Imaging in Diagnosing Participants With Glioma

Recruiting now · Phase 1

Conditions studied: Glioma

In brief

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.

Key facts

Study ID

NCT03739411

Run by

Susan Chang

People needed

140

Starts

2015-12-09

Expected to finish

2028-06-01

Last updated by the study team

2026-06-18

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Participants must be > 18 years old and with a life expectancy > 12 weeks.
• Participants must have a Karnofsky performance status of ≥ 60.
• 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.
• 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.
• Participants must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
• Participants must not have a 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. Patients must sign an authorization for the release of their protected health information.
• Participants may not be known to be human immunodeficiency virus (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 in complete remission and 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 child-bearing potential.

You may not qualify if…

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

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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