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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: Hyperfine MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperfine<br>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. | Diagnostic Test: Hyperfine MRI<br>* • 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US | Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US | Through study completion, an average of one year |