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

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.

Conditions4

Interventions1

Locations3 sites

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