Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

• Status: Recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

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 evaluate metabolism and aid in the non-invasive characterization of aggressive tumor behavior

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Javier Villaneuva-Meyer, MD
• Collaborators: General Electric; National Institute for Biomedical Imaging and Bioengineering (NIBIB)

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).

2. Participants cannot have contraindication to MRI examinations.

3. Age >=18 years.

4. Have a life expectancy of >12 weeks.

5. Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >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. Patients 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. Has New York Heart Association (NYHA) Grade II or greater congestive heart failure.

3. Has history of myocardial infarction or unstable angina within 12 months prior to study enrollment.

4. Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥>=90 mmHg) despite an optimized regimen of antihypertensive medication.

5. 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.

6. 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.

7. Participants must be excluded from participating in the study if they are not able to comply with the study and/or follow-up procedures.