Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

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

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.

Conditions4

Locations1 site

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