Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems (Contrast PMR)

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 Overview

• Status: Enrolling by invitation
• Conditions: Intra-axial Tumors; Extra-axial Tumors; Infection/Inflammatory Lesions
• Intervention / Treatment: Device: Portable MRI (pMRI); Drug: Gadolinium-Based Contrast Agent (GBCA)

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute
  • Texas
    • Dallas, Texas, United States, 75206
      • Texas Neurology
    • Tyler, Texas, United States, 75701
      • Christus Trinity Mother Frances Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6 months

Collaborators and Investigators

• Sponsor: Hyperfine

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 20254565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No