Using advanced MRI techniques to evaluate lower grade gliomas
Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate
This study is testing if advanced MRI techniques can help doctors better understand and track the growth of lower grade brain tumors in patients.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04540107 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of serial magnetic resonance imaging (MRI) and MR spectroscopic imaging (MRSI) in characterizing lower grade gliomas. The study aims to assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging for early detection of tumor progression and response to therapy. Participants will undergo MRI and MRSI scans, with some receiving hyperpolarized carbon C-13 pyruvate to enhance imaging results. The goal is to establish practical methods for evaluating and standardizing treatment in patients with brain tumors.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically proven lower grade gliomas who are being monitored with surveillance scans or those scheduled for treatment due to suspected tumor recurrence.
Not a fit: Patients with significant medical illnesses that cannot be controlled or those with advanced heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new imaging technique that allows for earlier detection of tumor progression and better monitoring of treatment response in patients with lower grade gliomas.
How similar studies have performed: Other studies utilizing advanced imaging techniques have shown promise, suggesting that this approach may yield valuable insights into glioma characterization.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Susan M Chang, MD — University of California, San Francisco
- Study coordinator: Wendy Ma
- Email: cancertrials@ucsf.edu
- Phone: 877-827-3222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.