Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Hyperfine
- Enrollment
- 85
- Locations
- 4
- Primary Endpoint
- Radiologist-rated lesion border delineation on post-contrast portable MRI
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be eligible to participate in this study, an individual must meet all the following criteria:
- •Age ≥18 years Clinical indication of suspected or known brain lesion(s) with focal blood-brain barrier disruption. Preferably, at least one previously documented brain lesion with focal areas of blood-brain barrier disruption categorizable as:
- •intra-axial tumor(s)
- •extra-axial tumor(s)
- •infection/inflammatory lesion(s)
- •Cleared for portable MRI (pMRI) and intravenous GBCA administration per site policy.
- •Adequate peripheral venous access for contrast injection.
- •Able to provide informed consent and comply with brief supine imaging (pre- and post-contrast)
Exclusion Criteria
- •Participants will be excluded if they meet any of the following criteria:
- •Metallic clips or devices in the brain or eye.
- •Body weight greater than 200 kg.
- •Inability to fit or be positioned appropriately within the Swoop® Portable MR Imaging® System.
- •Inability to remain still or lie flat during the imaging period.
- •Not cleared for GBCA administration due to known hypersensitivity, allergy, or contraindication.
- •Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or acute kidney injury.
- •History of severe reaction to any gadolinium-based contrast agent.
- •GBCA administration within the prior 48 hours (or alternative clearance window defined by institution)
- •Known or suspected pregnancy at the time of imaging.
Arms & Interventions
Single-Arm: Pre- and Post-Contrast pMRI
Participants will undergo portable magnetic resonance imaging (pMRI) using the Swoop® Portable MR Imaging® System (0.064 T), including imaging performed before and after intravenous administration of an FDA-approved gadolinium-based contrast agent (GBCA).
Intervention: Portable MRI (pMRI) (Device)
Single-Arm: Pre- and Post-Contrast pMRI
Participants will undergo portable magnetic resonance imaging (pMRI) using the Swoop® Portable MR Imaging® System (0.064 T), including imaging performed before and after intravenous administration of an FDA-approved gadolinium-based contrast agent (GBCA).
Intervention: Gadolinium-Based Contrast Agent (GBCA) (Drug)
Outcomes
Primary Outcomes
Radiologist-rated lesion border delineation on post-contrast portable MRI
Time Frame: 6 months
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.
Radiologist-rated lesion internal morphology visibility on post-contrast portable MRI
Time Frame: 6 months
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.
Radiologist-rated degree of contrast enhancement of target lesions on portable MRI
Time Frame: 6 months
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.
Radiologist-rated lesion border delineation on post-contrast portable MRI
Time Frame: 6 months
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.
Radiologist-rated lesion internal morphology visibility on post-contrast portable MRI
Time Frame: 6 months
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.
Radiologist-rated degree of contrast enhancement of target lesions on portable MRI
Time Frame: 6 months
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.
Secondary Outcomes
No secondary outcomes reported