Using hyperpolarized imaging to evaluate meningioma tumors

Pilot/Phase I Study of Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

This study is testing a new imaging method using a special substance to see if it can help doctors better understand the behavior of aggressive meningioma tumors in patients before surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06014905 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed meningioma that is measurable and scheduled for surgical resection.

Not a fit: Patients with contraindications to MRI or significant medical illnesses that may affect participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance non-invasive tumor characterization and improve treatment planning for patients with meningioma.

How similar studies have performed: While hyperpolarized imaging is a novel approach, similar studies have shown promise in other tumor types, indicating potential for success in this context.

Eligibility criteria

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 this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Javier Villanueva-Meyer, MD — University of California, San Francisco
• Study coordinator: Wendy Ma

Conditions Meningioma