This phase I trial evaluates new scanning technique hyperpolarized carbon 13 pyruvate (hyperpolarized 13C pyruvate) with magnetic resonance spectroscopic imaging (MRSI) for assessing and managing aggressive tumor behavior in patients with meningioma. Meningiomas are the most common primary intracranial (within the skull) tumor and are increasingly diagnosed as incidental findings. Imaging serves as an essential tool to monitor meningiomas that are not showing any symptoms and to determine the size and amount of tumor at various stages during the course of treatment. Hyperpolarized 13C pyruvate is a naturally occurring metabolite in humans. Pyruvate is part of sugar metabolism. The injectable agent is labelled with carbon-13 (13C) isotope, which does not change their metabolism but provides a magnetic resonance (MR) signal that allows the agents to be imaged. Magnetic resonance imaging (MRI) uses radio waves and a strong magnetic field rather than x-rays to provide amazingly clear and detailed pictures of internal organs and tissues. 13C pyruvate is administrated as a single injection before the MRI scan, allowing for imaging of tumor metabolism and blood flow. Information gained from this study may help researchers learn whether hyperpolarized 13C pyruvate with MRSI improves assessing and managing aggressive tumor behavior in patients with meningioma.
Additional locations may be listed on ClinicalTrials.gov for NCT06014905.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Contact: Javier Villanueva-Meyer
Phone: 415-353-1668
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 patients with meningioma.
SECONDARY OBJECTIVES:
I. To define the most appropriate parameters for obtaining hyperpolarized 13C data from meningioma patients with a run-in study in 20 patients with meningioma, to optimize spatial and temporal resolution and coverage by detecting signal amplitudes and time dynamics in these first-ever studies of meningioma patients.
II. To measure tumor pyruvate-to-lactate, pyruvate-to-alanine, and pyruvate-to-bicarbonate conversion by 13C pyruvate MR imaging by performing a phase 1 study of 30 patients with meningioma planning to undergo surgical resection within 4 weeks, using parameters defined in the first ten patients.
EXPLORATORY OBJECTIVES:
I. To evaluate the association between hyperpolarized 13C pyruvate MR and conventional MR imaging of meningioma (including qualitative and quantitative imaging features such as diffusion, perfusion, and steady state 1H spectroscopy).
II. To evaluate the association between hyperpolarized 13C pyruvate metabolism, and standard of care clinical pathology data determined from surgically resected tissue from surgery within 4 weeks after imaging, including pathological markers of aggressiveness (World Health Organization [WHO] grade and variant, Ki-67/MIB).
OUTLINE:
Patients receive hyperpolarized 13C pyruvate intravenously (IV) over 1 minute and undergo MRSI over 5 minutes on study. Patients also receive an additional gadolinium-based contrast agent IV before standard of care (SOC) MRI on study.
After completion of study intervention, patients are followed up to 30 days.
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorJavier Villanueva-Meyer
