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NCT07296263

Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

Enrolling by Invitation
NAAges 18+Interventional
Hyperfine
~85 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Portable MRI (pMRI)Gadolinium-Based Contrast Agent (GBCA)

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiologist-rated lesion border delineation on post-contrast portable MRI
Measured over 6 months
+2 more outcomes measured

Conditions

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

Explore related trials

Extra-axial TumorsInfectionIntra-axial Tumors

Where it's being run

6 sites across 5 states
Texas2
Florida1
Massachusetts1
New York1
Pennsylvania1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Radiologist-rated lesion border delineation on post-contrast portable MRI6 months

    Blinded neuroradiologists will assess lesion border delineation on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = poor delineation, 5 = excellent delineation). Scores will be summarized using descriptive statistics.

  • Radiologist-rated lesion internal morphology visibility on post-contrast portable MRI6 months

    Blinded neuroradiologists will evaluate the visibility of lesion internal morphology on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = non-visible, 5 = clearly visible). Scores will be summarized using descriptive statistics.

  • Radiologist-rated degree of contrast enhancement of target lesions on portable MRI6 months

    Blinded neuroradiologists will rate the degree of lesion contrast enhancement on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = no enhancement, 5 = marked enhancement). Ratings will be summarized descriptively across subjects.