Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07296263
NA

Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

Sponsor: Hyperfine

View on ClinicalTrials.gov

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

DEVICE

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.

DRUG

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