Extra-axial Tumors, Infection/Inflammatory Lesions, Intra-axial Tumors
Conditions
Brief summary
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
DEVICEPortable 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.
DRUGGadolinium-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.
Sponsors
Hyperfine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiologist-rated lesion border delineation on post-contrast portable MRI | 6 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 MRI | 6 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 MRI | 6 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. |
Countries
United States
Outcome results
None listed