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Enrolling by invitation NCT07296263

Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

No phase Interventional Intra-axial Tumors Extra-axial Tumors Infection/Inflammatory Lesions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Portable MRI (pMRI), Gadolinium-Based Contrast Agent (GBCA).
Who it may be relevant to
Registry conditions: Intra-axial Tumors, Extra-axial Tumors, Infection/Inflammatory Lesions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Portable 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.
  • Drug Gadolinium-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.

Primary outcome measures

  • Radiologist-rated lesion border delineation on post-contrast portable MRI [Time frame: 6 months]
  • Radiologist-rated lesion internal morphology visibility on post-contrast portable MRI [Time frame: 6 months]
  • Radiologist-rated degree of contrast enhancement of target lesions on portable MRI [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 6 centers
  • Neurology of Central Florida Research Center — Altamonte Springs
  • Massachusetts General Hospital — Boston
  • Dent Neurologic Institute — Amherst
  • Jefferson Abington Hospital — Abington
  • Texas Neurology — Dallas
  • CHRISTUS Trinity Mother Frances Health System — Tyler

Identifiers

NCT: NCT07296263 · 20254565

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗