Portable MRI for Emergencies

(PRIME Trial)

Overseen By Adam H de Havenon, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Pacemaker, Aneurysm clip, Implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the speed at which a portable MRI can begin scanning patients compared to a regular MRI in emergency situations. The goal is to determine if the portable MRI can enable doctors to start brain scans more quickly. Participants will receive either a portable MRI scan (Swoop Plus Mk2.0) along with standard care or just the usual standard care. Suitable candidates for this trial include those visiting the emergency department at Yale New Haven Hospital who are already scheduled for a regular brain MRI. As an unphased trial, this study allows participants to contribute to innovative research that could enhance the efficiency of emergency care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this portable MRI is safe for emergency use?

Research has shown that the Swoop Plus Mk2.0, a portable MRI machine, is safe for adults. The Food and Drug Administration (FDA) has approved it, confirming it meets safety standards. This machine can be used right at the patient's bedside, which is particularly beneficial for very sick patients, as it avoids the risks associated with moving them to a traditional MRI machine.

The portable MRI uses a weaker magnet than regular MRIs, making it gentler on the body. Studies have not linked any specific negative effects to this device. Testing in adult intensive care units has not reported any major safety problems.

In summary, the Swoop Plus Mk2.0 appears to be a safe and convenient choice for imaging, especially in emergencies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Portable MRI for Emergencies trial because it introduces a quick and convenient way to perform MRI scans right at the patient's bedside. Unlike traditional MRI machines, which are large and stationary, the Swoop Plus Mk2.0 is portable, making it easier to use in emergency situations where time is critical. This could speed up diagnosis and treatment decisions, potentially improving outcomes for patients who need rapid brain imaging. The hope is that this technology will make MRI scans more accessible, especially in settings where conventional MRI machines are not available, ultimately saving more lives in emergency situations.

What evidence suggests that the portable MRI is effective for emergency scans?

Research shows that portable MRI machines, like the Swoop Plus Mk2.0, can quickly and effectively scan the brain at the patient's bedside. In this trial, participants in the Portable Brain MRI scan arm will receive a portable MRI scan as part of their initial evaluation. Studies have found that these ultra-low-field MRIs, such as the Swoop, effectively identify stroke-related problems. This technology provides important diagnostic information rapidly, aiding doctors in making quicker decisions during emergencies. The Swoop system uses a magnet much weaker than those in traditional MRIs, facilitating its use in emergency situations. Overall, evidence supports portable MRIs as a useful tool in emergency medical care. ^{1 2 5 6 7}

Who Is on the Research Team?

Adam de Havenon, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for patients in the emergency department who require an MRI scan. Participants will be randomly assigned to receive either a portable MRI along with standard care or just standard care.

Inclusion Criteria

Order to receive conventional brain MRI imaging originating in the YNHH Adult ED

I am 18 years or older and was presented to Yale New Haven Hospital's Adult ED.

Exclusion Criteria

Lack of assent from treating physician for inclusion in this protocol

Contraindications to 1.5T MRI evaluation, including: Cardiac Pacemaker or defibrillator, Aneurysm clip, Implants or devices attached to the body in the chest or above such as Nerve stimulator, Deep brain stimulator, Programmable shunt, Stent, Pain pump, Artificial extremity, Implants in the ears (hearing aid or cochlear implant), Any shrapnel, pellets, bullets, metallic fragments, or other metallic foreign body above the chest, Metallic joints, rods, screws, or other orthopedic implants in or above the chest, Braces, dentures, removable teeth, or dental expanders that cannot be removed, Body piercings in or above the chest that cannot be removed, MRI-incompatible Tracheostomy tube or Swan Ganz catheter in place, History of uncontrolled seizures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Randomization and Initial Evaluation

Participants are randomized to receive either a portable MRI scan or standard of care. Initial evaluation includes receiving the portable MRI scan as soon as available for those in the scan arm.

1 day

1 visit (in-person)

Conventional MRI and Data Collection

All participants receive their scheduled conventional MRI. Data on clinical course, imaging, and length of stay are collected.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for outcomes such as time to scan start, percentage of completed scans, and provider satisfaction.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Swoop Plus Mk2.0

Trial Overview The study is testing the Swoop Plus Mk2.0, a portable MRI device, by comparing how quickly scans can start using it versus conventional MRIs in emergency settings.

How Is the Trial Designed?

Group I: Portable Brain MRI scan Experimental Treatment 1 Intervention

Participants in the scan arm will receive a portable MRI scan as soon as the scanner is available after randomization as part of their initial evaluation. Regardless of randomization arm, all participants will receive their scheduled conventional MRI as usual.

Group II: Standard of Care Active Control 1 Intervention

Participants in the SOC arm will not receive a portable MRI scan as part of their initial evaluation. Regardless of randomization arm, all participants will receive their scheduled conventional MRI as usual.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Hyperfine Research, Inc.

Collaborator

Hyperfine

Industry Sponsor

Published Research Related to This Trial

Portable, low-field magnetic resonance imagers can enhance the clinical assessment of stroke, providing valuable imaging support in emergency situations.

These devices have the potential to improve access to medical imaging resources, making it easier for more patients to receive timely and effective care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of stroke by portable, low-field MRI: A milestone in medical imaging. Basser, P.[2022]

A new portable MRI scanner prototype, weighing only 122 kg and using a low-field magnet, can produce high-quality brain images without the need for expensive infrastructure or cryogenics.

This scanner has the potential to improve access to brain MRI, especially for critically ill patients, by providing imaging capabilities directly at the point of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A portable scanner for magnetic resonance imaging of the brain. Cooley, CZ., McDaniel, PC., Stockmann, JP., et al.[2022]

In a study involving 14 neonates, 94% of portable MRI examinations were successfully completed without significant artefacts, indicating that this technology can be safely used in the NICU setting.

While portable MRI was effective in detecting significant intracranial pathologies, it missed some subtle abnormalities, suggesting that while it is a promising tool, it may not fully replace standard MRI examinations for all diagnostic needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of and experience using a portable MRI scanner in the neonatal intensive care unit. Sien, ME., Robinson, AL., Hu, HH., et al.[2022]

The American College of Radiology's updated guidance document on MR safety emphasizes the importance of addressing new risks and adverse events in the MR environment, ensuring safer practices for patients and personnel.

The latest recommendations include mandatory annual MR safety training for medical directors, highlighting the need for continuous education to adapt to evolving safety concerns in clinical and research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACR guidance document on MR safe practices: Updates and critical information 2019. Greenberg, TD., Hoff, MN., Gilk, TB., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40744719/

Clinical Use of the Swoop Portable MR Imaging System This video article gives an overview of the scanner characteristics, scan procedure, and representative clinical images obtained from our ...

2. withpower.com withpower.com/trial/phase-satisfaction-patient-3-2025-69734

Portable MRI for Emergencies (PRIME Trial) Research shows that portable MRI machines, like the Swoop Plus Mk2.0, can provide valuable diagnostic information quickly and at the patient's bedside, which is ...

3. hyperfinemri.com hyperfinemri.com/

Hyperfine, Inc. and the Swoop® Portable MR Imaging® ... The Swoop system is an AI-powered, portable brain MRI that uses a magnet with a fraction of the field strength used in conventional MRI.

4. investors.hyperfine.io investors.hyperfine.io/news-releases/news-release-details/latest-data-demonstrate-potential-swoopr-portable-mr-imagingr

Latest Data Demonstrate Potential of the Swoop® Portable ... New study utilizes Hyperfine, Inc. portable MRI system in monitoring brain injury and evaluating physiological impacts.

5. finance.yahoo.com finance.yahoo.com/news/favorable-data-swoop-portable-mri-144500006.html

Favorable Data on Swoop Portable MRI Likely to Support ... The study's findings reinforce the reliability of ultra-low-field MRI in identifying stroke-related abnormalities. This is a crucial advancement ...

6. 20597499.fs1.hubspotusercontent-na1.net 20597499.fs1.hubspotusercontent-na1.net/hubfs/20597499/Brochures%20and%20White%20Papers/Swoop%20Clinical%20and%20Business%20Value%20White%20Paper.pdf

Portable MR Imaging System™ Swoop® A new portable, point-of-care MRI system (the Swoop. Portable MR Imaging System) addresses the clinical risks, logistical challenges, and high costs associated.

7. investors.hyperfine.io investors.hyperfine.io/news-releases/news-release-details/hyperfine-swoopr-ai-powered-portable-mri-system-demonstrates-100

Hyperfine Swoop® AI-Powered Portable MRI System ... The Swoop® system achieved 100% sensitivity in detecting mild to moderate ARIA-E, a condition marked by cerebral edema. Researchers note that ...