Hyperpolarized Imaging in Diagnosing Patients with Glioma
This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing patients with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma and find out how far the disease has spread.
Inclusion Criteria
- FOR PATIENTS IN COHORT 1: Histologically proven glioma who have evidence of evaluable disease based on a prior MR scan.
- FOR PATIENTS IN COHORT 2: Histologically proven glioma who will be undergoing treatment
- Patients must be > 18 years old and with a life expectancy > 12 weeks.
- Patients must have a Karnofsky performance status of >= 60.
- Patients must have adequate renal function (creatinine < 1.5 mg/dL) before imaging. This test must be performed within 60 days prior to hyperpolarized imaging scan
- 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.
- Patients must not have New York Heart Association (NYHA) grade II or greater congestive heart failure.
- Patients 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.
- 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.
- Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.
- 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.
- 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
- Subjects must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.
Additional locations may be listed on ClinicalTrials.gov for NCT03739411.
Locations matching your search criteria
United States
California
San Francisco
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of hyperpolarized carbon C 13 (13C) magnetic resonance (MR) metabolic imaging as a new and unique tool for evaluating tumor burden and detecting early response to therapy in patients with glioma.
II. To define the most appropriate imaging parameters for obtaining hyperpolarized 13C data from the brain, one hundred patients with evidence of residual disease from a prior MRI examination will have hyperpolarized metabolic imaging after receiving one or two injection of hyperpolarized 13C pyruvate.
III. To establish the time course of changes in hyperpolarized pyruvate and lactate peaks on a voxel-by-voxel basis from the dynamic hyperpolarized data after the injection of hyperpolarized 13C pyruvate.
IV. To evaluate if patients who receive treatment exhibit a reduction in hyperpolarized 13C pyruvate lactate/pyruvate and/or 13C glutamate/pyruvate at post-treatment follow-up compared to their baseline scan.
COHORT I: Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo MRI. After 15-60 minutes, patients may receive a second injection of hyperpolarized carbon C 13 pyruvate and undergo MRI.
COHORT II: Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before standard treatment with radiation therapy and temozolomide at 4 weeks after completion of radiation therapy.
After completion of study treatment, patients are followed for up to 24 months.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorSusan Marina Chang
- Primary ID13106
- Secondary IDsNCI-2018-00939, 15-16749
- ClinicalTrials.gov IDNCT03739411