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RecruitingNot ApplicableNCT07296263

Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

Sponsor

Hyperfine

Enrollment

85 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Intra-axial TumorsExtra-axial TumorsInfection/Inflammatory Lesions

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria12

  • 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.
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Interventions

DEVICEPortable 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.

DRUGGadolinium-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.

Locations(3)

Dent Neurologic Institute

Amherst, New York, United States

Texas Neurology

Dallas, Texas, United States

CHRISTUS Trinity Mother Frances Health System

Tyler, Texas, United States

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NCT07296263