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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
85
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.
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.
Neurology of Central Florida Research Center
Altamonte Springs, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, 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
Radiologist-rated lesion border delineation on post-contrast portable MRI
Blinded neuroradiologists will assess lesion border delineation on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = poor delineation, 5 = excellent delineation). Scores will be summarized using descriptive statistics.
Time frame: 6 months
Radiologist-rated lesion internal morphology visibility on post-contrast portable MRI
Blinded neuroradiologists will evaluate the visibility of lesion internal morphology on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = non-visible, 5 = clearly visible). Scores will be summarized using descriptive statistics.
Time frame: 6 months
Radiologist-rated degree of contrast enhancement of target lesions on portable MRI
Blinded neuroradiologists will rate the degree of lesion contrast enhancement on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = no enhancement, 5 = marked enhancement). Ratings will be summarized descriptively across subjects.
Time frame: 6 months
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