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

Trial ID: NCT03739411

Interventional - Phase 1 - Recruiting

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

Interventions

• Hyperpolarized Carbon C 13 Pyruvate
• Magnetic Resonance Imaging
• Radiation Therapy
• Chemotherapy

Eligibility

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 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.

Sponsor

Susan Chang, National Cancer Institute (NCI)

Source: ClinicalTrials.gov

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