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

Trial Summary

What is the purpose of this trial?

Hyperfine Research, Inc. has taken advantage of technological advances and developed an MRI device that is not only portable, but also uses a very-low magnetic field strength, \[less than 0.2 Tesla or approximately 10 times less\] than the field strength of conventional devices. This critical difference allows HRI to address MRI's core challenges by, first, operating at very low magnetic field strengths, eliminating the need for special rooms or shielding. Second, there are minimal safety concerns regarding ferrous metals near the system, as the field strength is too low to attract metal objects. The removal of metal, including items such as jewelry, belts, etc. from clothing and person, prior to being scanned, is unnecessary. Third, the design constraints faced by conventional MRI systems are lifted at low magnetic field and an open device has been designed to minimize anxiety that may come with claustrophobic patients. All of this is possible while still providing image quality that is clinically relevant to a wide variety of fields, including radiology, neurology, pediatrics, emergency medicine, and others.

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 data supports the effectiveness of the treatment Hyperfine MRI, Swoop, Swoop Portable MR Imaging System, Hyperfine Swoop for brain imaging?

Research shows that portable low-field MRI systems, like the Hyperfine Swoop, can provide effective brain imaging by using low power and being easily transportable, which allows for scanning outside traditional MRI environments. These systems have been shown to produce clinically useful images with good contrast and reduced sensitivity to motion, making them accessible and practical for bedside imaging. ^{1 2 3 4 5}

Is Low Field MRI for Brain Imaging safe for humans?

Low Field MRI systems, like the Hyperfine Swoop, are generally considered safe for humans. Studies have shown that these systems can improve patient comfort by reducing noise and providing more space, and they meet safety standards set by organizations like the FDA. ^{6 7 8 9 10}

How is the Hyperfine MRI treatment different from other brain imaging treatments?

The Hyperfine MRI, also known as Swoop, is unique because it uses a portable, low-field magnet that is lightweight and does not require the heavy infrastructure of traditional MRI machines. This makes it more accessible and allows for brain imaging at the point of care, especially for critically ill patients, without the need for a dedicated MRI suite. ^{2 3 5 11 12}

Research Team

Sherwin Chan, MD PhD

Principal Investigator

Children's Mercy Kansas City

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

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

3. England pubmed.ncbi.nlm.nih.gov

Brain imaging with portable low-field MRI. [2023]

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

Accessible magnetic resonance imaging. [2004]

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

Low-Field Magnetic Resonance Imaging: Its History and Renaissance. [2023]

6. Switzerland 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. [2022]

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

Measurements of the ripple effect and geometric distribution of switched gradient fields inside a magnetic resonance scanner. [2015]

8. United States 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. [2018]

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

MRI-related FDA adverse event reports: A 10-yr review. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

Short-term side-effects of brain MR examination at 7 T: a single-centre experience. [2021]

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

Low-Cost High-Performance MRI. [2019]

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

High-sensitivity in vivo contrast for ultra-low field magnetic resonance imaging using superparamagnetic iron oxide nanoparticles. [2023]