Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate
Trial ID: NCT04540107
Interventional - Phase 1 - Recruiting
This trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.
Conditions
Recurrent World Health Organization (WHO) Grade II Glioma
Recurrent WHO Grade III Glioma
WHO Grade II Glioma
WHO Grade III Glioma
Interventions
Hyperpolarized Carbon C 13 Pyruvate
Magnetic Resonance Imaging
Magnetic Resonance Spectroscopic Imaging
Eligibility
Inclusion criteria
- For patients in cohort 1: histologically proven lower grade glioma who are being followed with surveillance scans
For patients in cohort 2: histologically proven glioma who are scheduled for treatment due to suspected residual or recurrent tumor
Patients 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. These tests must be performed within 60 days prior to the 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 participate in this study or any disease that will obscure toxicity or dangerously impact 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 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 they are in complete remission and have been off 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 will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures