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Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems
Sponsor: Hyperfine
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
85
Start Date
2025-12-30
Completion Date
2026-10-31
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
Portable MRI (pMRI)
Portable magnetic resonance imaging (pMRI) performed using the Swoop® Portable MR Imaging® System (0.064 T), including acquisition of pre-contrast and post-contrast images.
Gadolinium-Based Contrast Agent (GBCA)
Intravenous administration of an FDA-approved gadolinium-based contrast agent (GBCA) according to institutional standard-of-care dosing, administered between pre-contrast and post-contrast pMRI imaging.
Locations (3)
Dent Neurologic Institute
Amherst, New York, United States
Texas Neurology
Dallas, Texas, United States
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, United States