Hyperpolarized Imaging in Diagnosing Participants With Glioma

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Susan Chang
• Collaborator: National Cancer Institute (NCI)
• Treatments: Temozolomide

Criteria

Inclusion Criteria:

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

For Patients in Cohort 2: Histologically proven glioma who will be undergoing standard treatment with radiation and temozolomide.

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

1. Patients must be > 18 years old and with a life expectancy > 12 weeks.

2. Patients must have a Karnofsky performance status of ≥ 60.

3. Patients 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. Patients 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. Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure

6. Patients 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. Patients 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. Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.

10. Patients 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 of all therapy for that disease for a minimum of 3 years.

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