Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
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
| Condition(s) | Meningioma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 |
| Who can participate | 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. Particip |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Javier Villaneuva-Meyer, MD |
| Locations | San Francisco, California, United States |
| Start date | 2023-09-01 |
| NCT ID | NCT06014905 |
| Official listing | https://clinicaltrials.gov/study/NCT06014905 |