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

Hyperfine

Status: Enrolling

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

Treatments: Other: Evaluation of Gadolinium Based Contrast Agents (GBCA) for Portable MR Imaging Systems

Study type: Interventional

Funder types: Industry

Identifiers

NCT07296263

20254565

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Study inclusion criteria:

Subjects must meet ALL of the following inclusion criteria to be eligible for enrollment:

1. Age ≥18 years.
2. Clinical target: Highly suspected brain lesion(s) with focal blood-brain barrier disruption (preferably documented on prior standard-of-care high-field MRI within the past 60 days).
3. MRI/contrast approval: Cleared for pMRI and for approved IV GBCA administration per site policy.
4. IV access: Adequate peripheral venous access for contrast injection.
5. Consent/participation: Able to provide informed consent and comply with brief supine imaging (pre- and postcontrast).

Exclusion criteria

• Subjects must not meet ANY of the following Exclusion criteria to be eligible for enrollment:

  • 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.
  • 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

Other group

Description:

This prospective, interventional, single-arm study will collect data from patients in the hospital and/or outpatient setting undergoing portable magnetic resonance imaging (pMRI) using the Swoop® Portable MR Imaging® System (0.064 T). Each participant will undergo a pre-contrast portable MRI (pMRI) imaging scan, followed by intravenous administration of an FDA approved gadolinium-based contrast agent (GBCA), and then complete a post-contrast pMRI imaging scan. The study will assess lesion visibility between pre- and postcontrast images to assess the added value of contrast enhancement.

Treatment:

Other: Evaluation of Gadolinium Based Contrast Agents (GBCA) for Portable MR Imaging Systems