Low Field MRI for Brain Imaging

Overseen By Sarah Foster

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

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new MRI system, the Hyperfine MRI, which uses lower magnetic strength to create brain images. The researchers seek to compare these images with those from standard MRI, CT, or ultrasound scans. The trial specifically includes patients at CMH Adele Hall Radiology, aged 0 days to 22 years, who are already receiving head imaging as part of their regular care. Participants must not have any metal implants that cannot be safely scanned by an MRI. As an unphased trial, participants can contribute to innovative imaging research that may enhance future diagnostic techniques.

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 MRI system is safe for brain imaging?

Research has shown that the Hyperfine MRI system is safe for brain scans. The U.S. Food and Drug Administration (FDA) has approved the Swoop® Portable MR Imaging® System for brain scans in people of all ages, indicating it has passed strict safety tests.

This system differs from regular MRIs by using a magnet with much lower power, making it portable and quick, which is convenient for bedside use. So far, no serious safety issues or side effects have been reported from using this system.

Overall, evidence suggests that the Hyperfine MRI is well-tolerated and safe for brain imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hyperfine MRI for brain imaging because it offers a unique, low-field alternative to traditional MRI machines. Unlike standard MRI options, which typically require large, expensive equipment, the Hyperfine MRI is portable and more cost-effective, making it accessible in a wider range of settings, including smaller clinics and potentially in remote areas. This new approach could revolutionize brain imaging by providing faster, more convenient access to critical diagnostic tools, especially where conventional MRI isn't available.

What evidence suggests that the Hyperfine MRI is effective for brain imaging?

Research has shown that the Hyperfine MRI system, known as the Swoop, effectively provides quick and accurate brain scans. Studies have found that it delivers results much faster than traditional MRI machines, with an average scan time of just 2.5 hours compared to the usual 27.7 hours. This portable system proves especially helpful in emergencies, such as stroke treatment, where every minute counts. It can produce real-time brain images within 15 minutes, viewable on an iPad. The FDA has approved the Swoop system for brain imaging, and it has reliably identified conditions during emergency stroke assessments. ^{1 4 5 6 7}

Who Is on the Research Team?

Sherwin Chan, MD PhD

Principal Investigator

Children's Mercy

Are You a Good Fit for This Trial?

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

Inclusion Criteria

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

Exclusion Criteria

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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo imaging assessments using the low field MRI system

3 years

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 trial is testing a new early stage MRI system called Hyperfine MRI, which uses low magnetic field strength to perform brain imaging assessments on patients.

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

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. 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.

2. 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.

3. 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.

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. wexnermedical.osu.edu wexnermedical.osu.edu/departments/innovations/neuronews/portablemri

Portable MRIs provide lifesaving bedside brain imaging for ... The Hyperfine Swoop assesses brain tissue in real time: Brain tissue images are delivered within 15 minutes; MRI results are displayed on an iPad; Physicians ...

6. 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 ...

7. investors.hyperfine.io investors.hyperfine.io/node/9001/pdf

February 6, 2025 The Swoop® Portable MR Imaging® system is U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. It is a.