Recruiting

Observational Study

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT05582785

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:

The objective of the study is to perform imaging assessments of an early stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength.

Conditions

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

Study ID

NCT05582785

Start date

Sep 1, 2022

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 22

Healthy Volunteers: Not accepted

Inclusion Criteria

Outpatients at CMH Adele Hall Radiology 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

500 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 3 years ]

Central Contacts and Locations

Central contacts

Maura Sien, MS, RT(R)

8163026065mesien@cmh.edu

Sarah Foster

8162343273ssfoster@cmh.edu

Locations

Children's Mercy Kansas City

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Maura Sien

8163026065mesien@cmh.edu

Amie Robinson

8163028311alrobinson@cmh.edu

Principal Investigator:

Sherwin Chan, MD PhD

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Feb 6, 2026

Last verified

Feb, 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 2026-02-06.