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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
2026-06-25
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 (5)
Neurology of Central Florida Research Center
Altamonte Springs, Florida, United States
Dent Neurologic Institute
Amherst, New York, United States
Jefferson Abington Hospital
Abington, Pennsylvania, United States
Texas Neurology
Dallas, Texas, United States
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, United States