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Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

NCT ID: NCT07296263

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The Swoop® Portable MR Imaging® System was originally cleared by the U.S. Food and Drug Administration (FDA) on February 6, 2020, under 510(k) number K192002, and has undergone several FDA-cleared updates since its initial clearance. The most recent update was cleared on May 30, 2025, under 510(k) number K250236. All hardware used in this study will be covered under one of these FDA clearances. However, certain imaging sequences utilized for research purposes may be investigational and are not part of the cleared indications for use. The intent of the study is to demonstrate the established benefits of gadolinium-based contrast agents are observable in T1W images at 64 mT. All systems used will be FDA cleared hardware. Investigational-use only imaging sequences may be used for image collection; however, all hardware-imposed safety limitations will remain in place.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems

This prospective, interventional, single-arm study will collect data from patients in the hospital and/or outpatient setting undergoing portable magnetic resonance imaging (pMRI) using the Swoop® Portable MR Imaging® System (0.064 T). Each participant will undergo a pre-contrast portable MRI (pMRI) imaging scan, followed by intravenous administration of an FDA approved gadolinium-based contrast agent (GBCA), and then complete a post-contrast pMRI imaging scan. The study will assess lesion visibility between pre- and postcontrast images to assess the added value of contrast enhancement.

Group Type OTHER

Evaluation of Gadolinium Based Contrast Agents (GBCA) for Portable MR Imaging Systems

Intervention Type OTHER

This prospective, interventional, single-arm study will collect data from patients in the hospital and/or outpatient setting undergoing portable magnetic resonance imaging (pMRI) using the Swoop® Portable MR Imaging® System (0.064 T). Each participant will undergo a pre-contrast portable MRI (pMRI) imaging scan, followed by intravenous administration of an FDA approved gadolinium-based contrast agent (GBCA), and then complete a post-contrast pMRI imaging scan. The study will assess lesion visibility between pre- and postcontrast images to assess the added value of contrast enhancement.

Interventions

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Evaluation of Gadolinium Based Contrast Agents (GBCA) for Portable MR Imaging Systems

This prospective, interventional, single-arm study will collect data from patients in the hospital and/or outpatient setting undergoing portable magnetic resonance imaging (pMRI) using the Swoop® Portable MR Imaging® System (0.064 T). Each participant will undergo a pre-contrast portable MRI (pMRI) imaging scan, followed by intravenous administration of an FDA approved gadolinium-based contrast agent (GBCA), and then complete a post-contrast pMRI imaging scan. The study will assess lesion visibility between pre- and postcontrast images to assess the added value of contrast enhancement.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hyperfine

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Texas Neurology

Dallas, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Miriam S Rubelt, Dr.rer.nat.

Role: CONTACT

Phone: (866) 796-6767

Email: [email protected]

Monserrat Baeza, BS

Role: CONTACT

Phone: (866) 796-6767

Email: [email protected]

Facility Contacts

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Mohamad Nasri, MD

Role: primary

Related Links

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https://hyperfinemri.com/

Related Info

Other Identifiers

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20254565

Identifier Type: -

Identifier Source: org_study_id