NCT06014905 · Javier Villaneuva-Meyer, MD
Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
What this study is about
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
View original scientific description
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
Interventions
DRUG
Hyperpolarized carbon C 13 pyruvate
Given Intravenously (IV)
PROCEDURE
Magnetic Resonance Image (MRI)
Imaging procedure
OTHER
Saline
Given IV
Primary outcome measures
Proportion of participants who complete 13C pyruvate MR imaging.
Time frame: Day of MR imaging (1 day)
All participants who are enrolled in the study and receive any amount of hyperpolarized 13C pyruvate will be included in the primary outcome analysis. The proportion of participants who complete hyperpolarized 13C pyruvate MR imaging will be reported. If the proportion is greater than 0.7, hyperpolarized 13C MR imaging will be determined to be feasible.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Participants cannot have contraindication to MRI examinations.
- Age \>=18 years.
- Have a life expectancy of \>12 weeks.
- Karnofsky Performance Status \> 60%.
- 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.
- Participants must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Participants must sign an authorization for the release of their protected health information.
Exclusion criteria
- 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.
- Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥\>=90 mmHg) despite an optimized regimen of antihypertensive medication.
- 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.
- 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.
- 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
- San Francisco, California
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB), General Electric, National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations