WHO Grade III Glioma Clinical Trial
Official title:
Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Susan Chang | GE Healthcare, Phillips-Medisize, Sigma-Aldrich |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of treatment-emergent adverse events (AEs) | Safety evaluation for endpoint will include monitoring for the occurrence of treatment-emergent adverse events (AEs). Reported toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0. All available safety data will be used and will be analyzed using descriptive statistics. | Up to 4 years | |
Primary | Peak lactate/pyruvate | The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported. | Up to 4 years | |
Primary | Peak bicarbonate/pyruvate | The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported. | Up to 4 years | |
Primary | Change in peak lactate/pyruvate between scans | The change in peak lactate/pyruvate between scans will be reported. | Baseline up to 4 years | |
Primary | Change in peak bicarbonate/pyruvate between scans | The change in peak bicarbonate/pyruvate between scans will be reported. | Baseline up to 4 years |
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