Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

Launched by JAVIER VILLANEUVA-MEYER, MD · Aug 23, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a special imaging technique called hyperpolarized magnetic resonance imaging (MRI) to study meningiomas, which are tumors that can develop in the brain. The goal is to see how these tumors behave by examining their metabolism, which refers to how they use energy and nutrients. This could help doctors better understand the tumors without needing invasive procedures. The trial is currently looking for participants aged 18 and older who have been diagnosed with a meningioma that can be seen on MRI scans.

To participate, individuals must have a measurable tumor that is large enough and shows specific characteristics on imaging. Other important requirements include having a reasonable life expectancy, good kidney function, and being able to undergo an MRI. Participants will need to consent to the study and agree to share their health information. If eligible, those who join the study will receive the hyperpolarized imaging scan and contribute to important research that could improve how meningiomas are diagnosed and treated in the future.

Gender

ALL

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.