Using hyperpolarized imaging to evaluate meningioma tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot Phase I clinical study investigates the feasibility of using hyperpolarized 13C pyruvate injection combined with magnetic resonance imaging (MRI) to characterize aggressive behavior in meningioma tumors. Participants with confirmed meningioma will undergo a single imaging procedure to assess metabolic activity and tumor characteristics. The study aims to optimize imaging parameters and measure specific metabolic conversions in the tumors, providing insights into their behavior before surgical resection. Follow-up will occur for 30 days post-imaging to monitor outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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
2. Participants cannot have contraindication to MRI examinations.
3. Age \>=18 years.
4. Have a life expectancy of \>12 weeks.
5. Karnofsky Performance Status \> 60%.
6. 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.
7. Participants must sign an informed consent indicating that they are aware of the investigational nature of this study.
8. Participants must sign an authorization for the release of their protected health information.

Exclusion Criteria:

1. 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.
2. Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥\>=90 mmHg) despite an optimized regimen of antihypertensive medication.
3. 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.
4. 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.
5. Participants must be excluded from participating in the study if they are not able to comply with the study and/or follow-up procedures.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Charlie Wang, MD, PhD — University of California, San Francisco
• Study coordinator: Wendy Ma
• Email: Wendy.Ma@ucsf.edu
• Phone: (415) 514-4418

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.