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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Swoop Plus Mk2.0?

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 especially useful in emergency situations. Studies have demonstrated that portable MRI can effectively aid in diagnosing conditions like stroke, offering similar results to traditional MRI without needing to move patients to a dedicated imaging suite. ^{1 2 3 4 5}

Is the portable MRI scanner safe for use in humans?

The portable MRI system, also known as Swoop Plus Mk2.0, has been cleared by the Food and Drug Administration and shown to be safe in adult intensive care settings. ^{2 6 7 8 9}

How is the Swoop Plus Mk2.0 treatment different from other treatments for emergencies?

The Swoop Plus Mk2.0 is unique because it is a portable MRI system that can be used in various settings, including outdoors and at home, unlike traditional MRI machines that are large and require a controlled environment. This portability allows for immediate imaging in emergencies, making it more accessible and practical for use in remote or resource-limited areas. ^{3 5 10 11 12}

What is the purpose of this trial?

This study will compare the time it takes to scan a patient in the emergency department with a portable MRI when compared to a conventional MRI. Participants will be randomized to receive a portable MRI plus standard of care (SOC) vs SOC. Investigators will look at time to beginning of scan for both.

Research Team

Adam de Havenon, MD

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Emerging Techniques and Future Directions: Fast and Portable Magnetic Resonance Imaging. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility of and experience using a portable MRI scanner in the neonatal intensive care unit. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

MRI at the Bedside: A Case Report Comparing Fixed and Portable Magnetic Resonance Imaging for Suspected Stroke. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Portable magnetic resonance imaging of patients indoors, outdoors and at home. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness and relevance of MR acceptance testing: results of an 8 year audit. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Near Miss in Intraoperative Magnetic Resonance Imaging: A Case for In Situ Simulation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

ACR guidance document on MR safe practices: Updates and critical information 2019. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Easing anxiety in preparation for pediatric magnetic resonance imaging: a pilot study using animal-assisted therapy. [2020]

10. England pubmed.ncbi.nlm.nih.gov

On-site construction of a point-of-care low-field MRI system in Africa. [2023]

11. England pubmed.ncbi.nlm.nih.gov

A portable scanner for magnetic resonance imaging of the brain. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

The MR Cap: A single-sided MRI system designed for potential point-of-care limited field-of-view brain imaging. [2020]