Recruiting

Magnetic Resonance Imaging

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT04629469

Conditions

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

Eligibility Criteria

Sex: All

Age: 0 - 22

Healthy Volunteers: Not accepted

Interventions

Hyperfine MRI

Study Details

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 ID

NCT04629469

Start date

Oct 1, 2020

Status verified date

Jan, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 22

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US [ Time Frame: Through study completion, an average of one year ]

Central Contacts and Locations

Central contacts

Maura Sien, MS,RT(R)

8163028311mesien@cmh.edu

Locations

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Principal Investigator:

Sherwin Chan, MD,PHD

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2026-01-08.