Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

Enrolling by invitation · Not applicable

Conditions studied: Intra-axial Tumors, Extra-axial Tumors, Infection/Inflammatory Lesions

In brief

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 facts

Study ID

NCT07296263

Run by

Hyperfine

People needed

85

Starts

2025-12-30

Expected to finish

2026-10-31

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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