Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

NCT07296263 | Enrolling By Invitation FDA Device

• 1 other identifier: 20254565
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 3

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.

Conditions

Intra-axial Tumors; Extra-axial Tumors; Infection/Inflammatory Lesions

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Single-Arm: Pre- and Post-Contrast pMRI

EXPERIMENTAL

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); Drug: Gadolinium-Based Contrast Agent (GBCA)

Interventions

Portable MRI (pMRI) DEVICE

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.

Single-Arm: Pre- and Post-Contrast pMRI

Gadolinium-Based Contrast Agent (GBCA) DRUG

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.

Single-Arm: Pre- and Post-Contrast pMRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Hyperfine: lead

Study Sites (3)

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Texas Neurology

Dallas, Texas, 75206, United States

Location

CHRISTUS Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 22, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)