Low Field Magnetic Resonance Imaging Assessment With Outpatients

Children's Mercy Hospital Kansas City

Status: Enrolling

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

Treatments: Diagnostic Test: Hyperfine MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT05582785

STUDY00002266

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: Under 22 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

500 participants in 1 patient group

Hyperfine

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Hyperfine MRI