Low Field MRI for Brain Imaging

Overseen By Amie Robinson, BSRT(R)(MR)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Non-MRI conditional device, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of MRI machine, the Hyperfine MRI, which is portable and uses a very low magnetic field, enhancing safety and comfort. The goal is to determine if this machine can provide clear brain images without requiring special rooms or the removal of metal items like jewelry. Individuals who may benefit include those needing brain scans, particularly if they experience anxiety in traditional MRI machines. It is designed for patients at CMH Adele Hall, from newborns to young adults up to 22 years old. Those with non-removable or unsafe metal implants cannot participate. As an unphased trial, this study offers a unique opportunity to experience cutting-edge technology that could revolutionize brain imaging.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that sedation, if already administered, will not be altered for the study.

What prior data suggests that this MRI device is safe for brain imaging?

Research has shown that the Hyperfine MRI, also known as the Swoop® Portable MR Imaging® System, is safe and easy for patients to use. This MRI employs a much weaker magnetic field than traditional MRI machines—about ten times less. With this lower magnetic field, there are fewer safety concerns regarding metal objects, allowing patients to keep items like jewelry or belts on during the scan.

The FDA has approved the system for brain imaging in people of all ages, confirming it meets safety standards. Its lower magnetic field enhances safety for those with metal in their bodies. Additionally, the machine's open and portable design reduces feelings of confinement, offering more comfort for individuals who feel anxious in tight spaces. Overall, the Hyperfine MRI provides a safe and comfortable option for brain imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Hyperfine MRI is unique because it offers low-field imaging, which is a game-changer for brain imaging. Traditional MRI machines are large, expensive, and not easily accessible in many settings. However, Hyperfine MRI is compact and portable, making it possible to bring imaging directly to patients, even in remote or resource-limited areas. Researchers are excited about this technology because it has the potential to make brain imaging more accessible and affordable, without sacrificing diagnostic quality.

What evidence suggests that this MRI device is effective for brain imaging?

Research has shown that the Hyperfine MRI system, known as the Swoop, holds promise for brain scans. Studies have found it can perform scans much faster, averaging about 2.5 hours compared to the usual 27.7 hours with regular MRIs. This speed proves particularly useful in emergencies, such as stroke treatment. The Swoop is portable and uses a lower magnetic field, eliminating the need for special rooms or shielding. It also reduces anxiety for patients who feel claustrophobic in traditional MRI machines. Additionally, the FDA has approved the Swoop for brain imaging, confirming its trustworthiness for medical use. ^{1 6 7 8 9}

Who Is on the Research Team?

Sherwin Chan, MD PhD

Principal Investigator

Children's Mercy Kansas City

Are You a Good Fit for This Trial?

This trial is for pediatric patients aged from birth to 22 years at CMH Adele Hall. It's not suitable for those who need extra sedation or have non-MRI safe implants that can't be removed.

Inclusion Criteria

I am between 0 days and 22 years old and an inpatient at CMH Adele Hall.

Exclusion Criteria

My current sedation plan won't change for this study.

Any patient who has a contraindication to having an MRI, such as: Non-MRI conditional implanted device or device that is not able to be removed for MRI examination.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo MRI assessments using the Hyperfine MRI device to compare with standard of care imaging

1 year

Follow-up

Participants are monitored for safety and effectiveness after imaging assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperfine MRI

Trial Overview The study tests a new portable MRI device by Hyperfine Research, which operates at very low magnetic fields and doesn't require special rooms or metal removal, aiming to reduce patient anxiety.

How Is the Trial Designed?

Group I: Hyperfine Experimental Treatment 1 Intervention

For patients that have standard of care head imaging, we will do a secondary analysis to compare their standard of care MRI, CT and/or US exams with Hyperfine MRI exams.

Hyperfine MRI is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as Swoop for:

• Brain imaging of patients of all ages

Approved in European Union as Swoop for:

• Brain imaging

Approved in United Kingdom as Swoop for:

• Brain imaging

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Published Research Related to This Trial

A new ultra-low magnetic field MRI technique operates at just 6.5 mT, which is over 450 times lower than traditional MRI scanners, yet achieves impressive imaging resolution of (2.5 × 3.5 × 8.5) mm³ in the human brain.

This innovative approach combines modern imaging strategies with a simple, non-cryogenic electromagnet, making MRI technology more affordable (under $50,000) and portable, potentially expanding access to MRI in various environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Cost High-Performance MRI. Sarracanie, M., LaPierre, CD., Salameh, N., et al.[2019]

Portable MRI systems are being developed to improve access to MRI imaging, but challenges like magnetic field inhomogeneity can degrade image quality, particularly in small, high-field systems.

High-field MRI (1.5 T or greater) offers better signal-to-noise ratio and image contrast, allowing for higher resolution images, but also faces issues with field inhomogeneity that can lead to signal dropout and distortion, necessitating new strategies to mitigate these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary approaches to high-field magnetic resonance imaging with large field inhomogeneity. Mullen, M., Garwood, M.[2021]

The study measured the peak dB/dt exposure from switched gradient fields in a 1.5T MRI scanner, finding maximum values of 6-14 T/s at the edges of the field of view, which is important for understanding potential genotoxic effects during MRI procedures.

A significant distortion in dB/dt exposure was observed due to a 200 kHz ripple from the amplifier, leading to peak dB/dt values up to 18 times higher than expected, highlighting the need for careful assessment of gradient field exposure in MRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurements of the ripple effect and geometric distribution of switched gradient fields inside a magnetic resonance scanner. Sundström, H., Mild, KH., Wilén, J.[2015]

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]

Portable low-field MRI (LF-MRI) offers enhanced access to neuroimaging outside traditional MRI suites, making it suitable for various clinical situations that conventional MRI cannot easily address.

Recent advancements in noise cancellation, machine learning algorithms, and image enhancement techniques have improved the diagnostic quality of LF-MRI, paving the way for its use in both healthy brain visualization and the detection of neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain imaging with portable low-field MRI. Kimberly, WT., Sorby-Adams, AJ., Webb, AG., et al.[2023]

Ultra-low field (ULF) MRI, using superparamagnetic iron oxide nanoparticles (SPIONs), can achieve high-contrast images in a rat model while maintaining short scan times, addressing a major challenge in ULF MRI technology.

This advancement in ULF MRI allows for the use of biocompatible contrast agents, potentially expanding the clinical accessibility and application of MRI for disease detection with portable scanners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-sensitivity in vivo contrast for ultra-low field magnetic resonance imaging using superparamagnetic iron oxide nanoparticles. Waddington, DEJ., Boele, T., Maschmeyer, R., et al.[2023]

Recent advancements in low-field MRI technology have improved their performance, making them more clinically useful than previously thought, despite their lower cost.

High-performance low-field MRI systems now offer unique advantages over traditional high-field MRI systems, expanding their potential applications in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Field Magnetic Resonance Imaging: Its History and Renaissance. Hori, M., Hagiwara, A., Goto, M., et al.[2023]

Patients reported significantly higher comfort levels when imaged on a 0.55T low-field MRI scanner compared to a conventional 1.5T scanner, with 78% rating their overall experience as 'better' or 'much better'.

The 0.55T MRI system not only provided a larger bore opening, which enhanced the sense of space for 84% of patients, but also produced lower noise levels during imaging, contributing to a more pleasant experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More Space, Less Noise-New-generation Low-Field Magnetic Resonance Imaging Systems Can Improve Patient Comfort: A Prospective 0.55T-1.5T-Scanner Comparison. Rusche, T., Vosshenrich, J., Winkel, DJ., et al.[2022]

Over a 10-year period, the FDA received 1568 reports of adverse events related to magnetic resonance (MR) systems, with 1548 reports analyzed, highlighting the importance of monitoring safety in MR imaging.

The most common serious injuries reported were thermal events, accounting for 59% of cases, followed by mechanical events (11%), projectile events (9%), and acoustic events (6%), indicating specific risks associated with MR environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-related FDA adverse event reports: A 10-yr review. Delfino, JG., Krainak, DM., Flesher, SA., et al.[2020]

High magnetic field strength in MRI systems is not a strong determinant of diagnostic performance, allowing for the development of effective low-field MRI systems that are more cost-efficient.

A new low-cost MRI system using a permanent magnet offers advantages such as reduced patient discomfort, easier access, and lower operational costs, making MRI more accessible to a wider population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accessible magnetic resonance imaging. Kaufman, L., Arakawa, M., Hale, J., et al.[2004]

The newly developed compact three-tesla MRI system successfully meets the American College of Radiology's image quality standards, ensuring high-quality imaging for clinical use.

The system also complies with FDA noise limits, demonstrating that it can operate with minimal acoustic disturbance while effectively correcting geometric distortion through advanced spherical harmonic techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical Note: Compact three-tesla magnetic resonance imager with high-performance gradients passes ACR image quality and acoustic noise tests. Weavers, PT., Shu, Y., Tao, S., et al.[2018]

In a study of 180 subjects undergoing brain imaging with a 7 Tesla MRI, 51% reported mild side effects, but none were serious and did not require interruption of the examination.

The overall tolerability was high, with a mean discomfort score of only 1.1 out of 15, and discomfort decreased as operators gained more experience with the ultrahigh field MRI system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term side-effects of brain MR examination at 7 T: a single-centre experience. Cosottini, M., Frosini, D., Biagi, L., et al.[2021]

Citations

1. investors.hyperfine.io investors.hyperfine.io/news-releases/news-release-details/hyperfine-announces-promising-interim-findings-value-portable

News Release Details The Swoop® Portable MR Imaging® system shows faster time-to-scan compared to conventional MRI and good specificity in emergency stroke care.

2. hyperfinemri.com hyperfinemri.com/assets/pdfs/Hyperfine,%20Inc.%20DL%20Image%20Reconstruction%20White%20Paper%20-%20LBL-001364%20v1.pdf

Portable MR Imaging System™ Swoop® The Swoop Portable MR Imaging System is a trans- formational diagnostic Magnetic Resonance Imaging system. Cleared by the FDA in 2020 for brain imaging for.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10576557/

Current role of portable MRI in diagnosis of acute ... Benefits of pMRI include timely and accurate detection of major acute neurological pathologies such as stroke and intracranial hemorrhage.

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/hyperfine-swoop-mri-system-trumps-standard-mris-in-interim-study/

Hyperfine's Swoop MRI system trumps standard MRIs in ... Hyperfine revealed data that the Swoop system outperformed conventional MRI in speed, with a median time-to-scan of 2.5 hours compared to 27.7 hours.

5. 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.

6. ajnr.org ajnr.org/content/early/2025/07/31/ajnr.A8907

Clinical Use of the Swoop Portable MR Imaging System The ultra-low-field environment also allows for decreased susceptibility artifacts and improved safety, allowing patients with active and ...

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

Hyperfine Swoop® AI-Powered Portable MRI System ... The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They ...

8. 20597499.fs1.hubspotusercontent-na1.net 20597499.fs1.hubspotusercontent-na1.net/hubfs/20597499/Brochures%20and%20White%20Papers/Swoop%20Clinical%20Use%20Case%20White%20Paper.pdf

Portable MR Imaging System™ Swoop® Hyperfine designed the Swoop system to address the limitations of current imaging technologies and make MRI accessible anytime, anywhere, and to any patient.

9. jeffersonhealth.org jeffersonhealth.org/about-us/news/2023/06/portable-mri-system

Jefferson Abington Hospital Introduces Innovative New ... The SWOOP is portable and has a much lower magnetic field strength, which means we can have brain imaging completed right in the patient's room.