Intra-axial TumorsContrast PMRNCT07296263
Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems
A study testing Portable MRI (pMRI) and Gadolinium-Based Contrast Agent (GBCA) in people with Intra-axial Tumors and Extra-axial Tumors, run by Hyperfine at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-axial Tumors, Extra-axial Tumors, Infection/Inflammatory Lesions
- What is being tested?
- Portable MRI (pMRI) and Gadolinium-Based Contrast Agent (GBCA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Dec 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Jefferson Abington Hospital
Abington, Pennsylvania, 19001
Neurology of Central Florida Research Center
Altamonte Springs, Florida, 32714
Dent Neurologic Institute
Amherst, New York, 14226
Massachusetts General Hospital
Boston, Massachusetts, 02114
Texas Neurology
Dallas, Texas, 75206
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, 75701
About this study
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.
- Being tested
- Portable MRI (pMRI), Gadolinium-Based Contrast Agent (GBCA)
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Portable MRI (pMRI); Drug: Gadolinium-Based Contrast Agent (GBCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start30 Dec 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-axial TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyperfine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296263
- Sponsor's protocol ID
- 20254565
- Acronym
- Contrast PMR
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems
- ClinicalTrials.gov ID
- NCT07296263
- Acronym / sponsor ID
- Contrast PMR / 20254565
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- HyperfineIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single-Arm: Pre- and Post-Contrast pMRI | Experimental | Device: Portable MRI (pMRI), Drug: Gadolinium-Based Contrast Agent (GBCA)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Single-Arm: Pre- and Post-Contrast pMRI |
| 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. | Drug | Single-Arm: Pre- and Post-Contrast pMRI |
Primary outcome
Radiologist-rated lesion border delineation on post-contrast portable MRI
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable MRI (pMRI) and Gadolinium-Based Contrast Agent (GBCA) in people with Intra-axial Tumors and Extra-axial Tumors, run by Hyperfine at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiologist-rated lesion border delineation on post-contrast portable MRI (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.