Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Dec 30, 2025

Status verified

Jun 2026

Primary completion

Jul 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

85 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: Single-Arm: Pre- and Post-Contrast pMRI
  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).

Primary Outcome Measure

Radiologist-rated lesion border delineation on post-contrast portable MRI [ Time Frame: 6 months ]

Locations (4)

Find similar trials in Amherst, NY