Status:
RECRUITING
Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
Lead Sponsor:
Javier Villaneuva-Meyer, MD
Collaborating Sponsors:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
General Electric
Conditions:
Meningioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 eval...
Detailed Description
Primary Objective: I. To assess the feasibility of hyperpolarized 13C MR imaging as a new and unique tool in the characterization of aggressive tumor behavior in participants with meningioma. Second...
Eligibility Criteria
Inclusion
- Known (histopathologically confirmed) or presumed meningioma based on imaging with measurable disease on MRI that shows gadolinium enhancement (at least one cm diameter) intracranially (e.g., not confined to skull base alone).
- a. Thirty of the participants plan to have surgical resection within 4 weeks
- Participants cannot have contraindication to MRI examinations.
- Age \>=18 years.
- Have a life expectancy of \>12 weeks.
- Karnofsky Performance Status \> 60%.
- Participants 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.
- Participants must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Participants must sign an authorization for the release of their protected health information.
Exclusion
- Has 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.
- Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥\>=90 mmHg) despite an optimized regimen of antihypertensive medication.
- Has 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.
- Participants 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 participants of child-bearing potential.
- Participants must be excluded from participating in the study if they are not able to comply with the study and/or follow-up procedures.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06014905
Start Date
September 1 2023
End Date
September 30 2026
Last Update
May 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Francisco
San Francisco, California, United States, 94143