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Ensaio clínico

Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

NCT: NCT07296263 · ACTIVE_NOT_RECRUITING

ID NCTNCT07296263
EstadoACTIVE_NOT_RECRUITING
Data de início2025-12-30
Conclusão2026-10-31
SponsorHyperfine (INDUSTRY)
First posted
Last updated

Resumo breve

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.

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