NCT06014905 Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
| NCT ID | NCT06014905 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Javier Villaneuva-Meyer, MD |
| Condition | Meningioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2023-09-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 evaluate metabolism and aid in the non-invasive characterization of aggressive tumor behavior
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.
Contact & Investigator
Javier Villanueva-Meyer, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06014905 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Meningioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06014905 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06014905 currently recruiting?
Yes, NCT06014905 is actively recruiting participants. Contact the research team at Wendy.Ma@ucsf.edu for enrollment information.
Where is the NCT06014905 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06014905 clinical trial?
NCT06014905 is sponsored by Javier Villaneuva-Meyer, MD. The principal investigator is Javier Villanueva-Meyer, MD at University of California, San Francisco. The trial plans to enroll 50 participants.