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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Arm: Pre- and Post-Contrast pMRI | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiologist-rated lesion border delineation on post-contrast portable MRI | 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. | 6 months |
| Radiologist-rated lesion internal morphology visibility on post-contrast portable MRI | 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. | 6 months |
| Radiologist-rated degree of contrast enhancement of target lesions on portable MRI | 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. | 6 months |
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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:
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:
Subjects may be selectively enrolled or excluded to ensure inclusion of radiology finding subgroups and GBCA agents.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology of Central Florida Research Center | Altamonte Springs | Florida | 32714 | United States | ||
| Dent Neurologic Institute |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| 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. |
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| Amherst |
| New York |
| 14226 |
| United States |
| Jefferson Abington Hospital | Abington | Pennsylvania | 19001 | United States |
| Texas Neurology | Dallas | Texas | 75206 | United States |
| CHRISTUS Trinity Mother Frances Health System | Tyler | Texas | 75701 | United States |
| ID | Term |
|---|---|
| D007239 | Infections |
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