Using hyperpolarized imaging to diagnose glioma

Pilot Study of Safety and Feasibility of Acquiring Hyperpolarized Imaging in Patients With Gliomas

This study is testing a new type of MRI using a special substance to see if it can help doctors better diagnose glioma in patients who have signs of leftover disease.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT03739411 on ClinicalTrials.gov

What this trial studies

This pilot trial evaluates the safety and feasibility of hyperpolarized carbon C-13 pyruvate magnetic resonance imaging (MRI) for diagnosing glioma. It involves one hundred participants with evidence of residual disease who will undergo hyperpolarized metabolic imaging after receiving one or two injections of hyperpolarized C-13 pyruvate. The study aims to determine the most effective imaging parameters and assess changes in metabolic signals over time, particularly in response to standard treatments like radiation and chemotherapy.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with histologically proven glioma and evidence of evaluable disease.

Not a fit: Patients with significant medical illnesses that cannot be controlled or those with conditions obscuring imaging results may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the accuracy of glioma diagnosis and monitoring treatment response.

How similar studies have performed: While hyperpolarized imaging is a novel approach, similar imaging techniques have shown promise in other studies, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

For Participants in Cohort 1: 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.

Where this trial is running

San Francisco, California

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

Study contacts

• Principal investigator: Susan Chang, MD — University of California, San Francisco
• Study coordinator: Wendy Ma

Conditions Glioma