Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

This is a prospective, multi-center, interventional study designed to evaluate the visualization benefits of FDA approved gadolinium-based contrast agents (GBCAs) in portable magnetic resonance imaging (pMRI) of the brain. The study will enroll adult patients with known or suspected brain lesions involving blood-brain barrier disruption. Each participant will undergo a pre-contrast pMRI scan, receive an intravenous GBCA injection, and then complete a post-contrast pMRI scan using the Swoop® Portable MR Imaging® System. Lesion visualization will be assessed by independent neuroradiologists using standardized scoring criteria. The study will be conducted across a minimum of three sites to ensure diversity in patient population, imaging environments, and GBCA types.

NCT Number	NCT07296263
Lead Sponsor	Hyperfine
Conditions	Intra-axial Tumors, Extra-axial Tumors, Infection/Inflammatory Lesions
Enrollment	85 participants
Start Date	2025-12-30
Primary Completion	2026-07-31 (estimated)
Study Completion	2026-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-15