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

NCT ID: NCT04629469

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2030-12-31

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.

Conditions

Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Hyperfine

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.

Group Type: EXPERIMENTAL

Hyperfine MRI

Intervention Type: DIAGNOSTIC_TEST

• Patients who have a standard of care MRI, CT or US will undergo a low-field MRI utilizing Hyperfine either at the patient's bedside or in the department of Radiology. Results of the Hyperfine MRI will not be used for clinical care and will only be available to members of the research team for review.

Interventions

Hyperfine MRI

• Patients who have a standard of care MRI, CT or US will undergo a low-field MRI utilizing Hyperfine either at the patient's bedside or in the department of Radiology. Results of the Hyperfine MRI will not be used for clinical care and will only be available to members of the research team for review.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Sherwin Chan MD PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherwin Chan, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Kansas City

Locations

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maura Sien, MS,RT(R)

Role: CONTACT

mesien@cmh.edu

8163028311

Facility Contacts

Maura Sien, BS,RT(R)

Role: primary

mesien@cmh.edu

8163026065

Sarah Foster

Role: backup

ssfoster@cmh.edu

8162343273

References

Sien ME, Robinson AL, Hu HH, Nitkin CR, Hall AS, Files MG, Artz NS, Pitts JT, Chan SS. Feasibility of and experience using a portable MRI scanner in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2023 Jan;108(1):45-50. doi: 10.1136/archdischild-2022-324200. Epub 2022 Jul 4.

Reference Type: DERIVED

PMID: 35788031 (View on PubMed)

Other Identifiers

STUDY00001356

Identifier Type: -

Identifier Source: org_study_id