Hyperpolarized MRI for Meningioma
Trial Summary
What is the purpose of this trial?
This is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that includes the acquisition of magnetic resonance (MR) data performed on participants with meningioma to evaluate metabolism and aid in the non-invasive characterization of aggressive tumor behavior
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have uncontrolled blood pressure despite medication, you may not be eligible to participate.
What data supports the effectiveness of the treatment Hyperpolarized carbon C 13 pyruvate for meningioma?
Research shows that hyperpolarized carbon-13 MRI, which uses hyperpolarized pyruvate, can effectively track tumor metabolism in brain cancers by highlighting changes in energy use within the tumor. This technique has been used in other brain tumors to provide detailed metabolic information, suggesting it could be useful for assessing meningiomas as well.12345
Is hyperpolarized 13C pyruvate safe for humans?
How is the treatment Hyperpolarized carbon C 13 pyruvate unique for meningioma?
Research Team
Javier Villanueva-Meyer, MD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
Adults (18+) with confirmed or presumed meningioma based on MRI scans can join this trial. They should have a life expectancy over 12 weeks, be able to give informed consent, and not have any health issues that would interfere with the study. Pregnant or breastfeeding women are excluded, as well as those with recent heart problems, uncontrolled blood pressure, other cancers within the last 3 years, or an inability to follow study procedures.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Imaging Procedure
Participants receive a single research MR imaging using HP 13C pyruvate, intravenously injected, followed by safety monitoring
Follow-up
Participants are monitored for safety and effectiveness after the imaging procedure, with clinical data obtained from medical records
Treatment Details
Interventions
- Hyperpolarized carbon C 13 pyruvate
- Magnetic Resonance Image (MRI)
- Saline
Hyperpolarized carbon C 13 pyruvate is already approved in United States for the following indications:
- Research use only, not approved for clinical use
Find a Clinic Near You
Who Is Running the Clinical Trial?
Javier Villaneuva-Meyer, MD
Lead Sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
General Electric
Industry Sponsor
National Cancer Institute (NCI)
Collaborator