Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems
Purpose
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.
Conditions
- Intra-axial Tumors
- Extra-axial Tumors
- Infection/Inflammatory Lesions
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible 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. - Any medical or behavioral condition that, in the investigator's judgment, would make participation unsafe or interfere with study completion. Subjects may be selectively enrolled or excluded to ensure inclusion of radiology finding subgroups and GBCA agents.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- The Swoop® Portable MR Imaging® System was originally cleared by the U.S. Food and Drug Administration (FDA) on February 6, 2020, under 510(k) number K192002, and has undergone several FDA-cleared updates since its initial clearance. The most recent update was cleared on May 30, 2025, under 510(k) number K250236. All hardware used in this study will be covered under one of these FDA clearances. However, certain imaging sequences utilized for research purposes may be investigational and are not part of the cleared indications for use. The intent of the study is to demonstrate the established benefits of gadolinium-based contrast agents are observable in T1W images at 64 mT. All systems used will be FDA cleared hardware. Investigational-use only imaging sequences may be used for image collection; however, all hardware-imposed safety limitations will remain in place.
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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). |
|
Recruiting Locations
Tyler, Texas 75701
More Details
- Status
- Recruiting
- Sponsor
- Hyperfine