Pilot Study of Feasibility of Acquiring Hyperpolarized Imaging in Patients With Primary CNS Lymphoma
James Rubenstein
Summary
This phase I trial evaluates the feasibility of using hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing patients with primary central nervous system lymphoma. This trial aims to see whether MRI using hyperpolarized carbon-13 pyruvate is safe and useful for detecting central nervous system lymphoma and evaluating response to treatment.
Description
PRIMARY OBJECTIVES 1. To determine the safety and tolerability of hyperpolarized 13C MR metabolic imaging as a new and unique tool in the evaluation of tumor burden and detecting early response to standard therapy in participants with PCNSL. 2. To assess the feasibility of hyperpolarized 13C as a new and unique tool in the evaluation of tumor burden and detecting early response to standard therapy in PCNSL participants. 3. To define the most appropriate imaging parameters for obtaining 13C data from PCNSL participants (Cohort 1, n=5). 4. To evaluate changes in Cohort 2 in imaging pre- and pos…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * For Patients in Cohort 1: Histologically proven relapsed PCNSL who have evidence of evaluable disease based on a prior MR scan, or relapsed CNS lymphoma: measurable disease based on MRI is defined as gadolinium enhancement of a CNS lymphoma lesion (at least one centimeter (cm) diameter). * For Patients in Cohort 2: Histologically proven newly diagnosed PCNSL who will receive standard treatment with high-dose methotrexate, temozolomide plus rituximab (MT-R). These criteria will ensure validity of this study in terms of safety, evaluation of clinically and radiographically…
Interventions
- DrugHyperpolarized pyruvate (13C)
Given intravenously (IV) injection prior to imaging
- ProcedureMagnetic resonance imaging (MRI)
MRI scan takes an image of brain and/or spinal cord and will take up to 45 minutes to complete
Location
- University of California, San FranciscoSan Francisco, California