Pilot/Phase I Study of Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
Javier Villaneuva-Meyer, MD
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
Description
Primary Objective: I. To assess the feasibility of hyperpolarized 13C MR imaging as a new and unique tool in the characterization of aggressive tumor behavior in participants with meningioma. Secondary Objectives: I. To define the most appropriate parameters for obtaining hyperpolarized 13C data from meningioma patients with a run-in study to optimize spatial and temporal resolution and coverage by detecting signal amplitudes and time dynamics. II. To measure tumor pyruvate-to-lactate, pyruvate-to-alanine, and pyruvate-to-bicarbonate conversion by 13C pyruvate MR imaging in participants wi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugHyperpolarized carbon C 13 pyruvate
Given Intravenously (IV)
- ProcedureMagnetic Resonance Image (MRI)
Imaging procedure
- OtherSaline
Given IV
Location
- University of California, San FranciscoSan Francisco, California