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Recruiting NCT04629469

NCT04629469 Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients

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Clinical Trial Summary
NCT ID NCT04629469
Status Recruiting
Phase
Sponsor Children's Mercy Hospital Kansas City
Condition Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound
Study Type INTERVENTIONAL
Enrollment 250 participants
Start Date 2020-10-01
Primary Completion 2030-12

Eligibility & Interventions

Sex All sexes
Min Age 0 Days
Max Age 22 Years
Study Type INTERVENTIONAL
Interventions
Hyperfine MRI

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 250 participants in total. It began in 2020-10-01 with a primary completion date of 2030-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria Inpatients at CMH Adele Hall ages 0 days to 22 years are eligible for enrollment. Exclusion Criteria No additional sedation will be given as part of this study and that sedation, if already administered, will not be altered for study purposes. 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

Contact & Investigator

Central Contact

Maura Sien, MS,RT(R)

✉ mesien@cmh.edu

📞 8163028311

Principal Investigator

Sherwin Chan, MD,PHD

PRINCIPAL INVESTIGATOR

Children's Mercy Kansas City

Frequently Asked Questions

Who can join the NCT04629469 clinical trial?

This trial is open to participants of all sexes, aged 0 Days or older, up to 22 Years, studying Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04629469 currently recruiting?

Yes, NCT04629469 is actively recruiting participants. Contact the research team at mesien@cmh.edu for enrollment information.

Where is the NCT04629469 trial being conducted?

This trial is being conducted at Kansas City, United States.

Who is sponsoring the NCT04629469 clinical trial?

NCT04629469 is sponsored by Children's Mercy Hospital Kansas City. The principal investigator is Sherwin Chan, MD,PHD at Children's Mercy Kansas City. The trial plans to enroll 250 participants.

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