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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-22
SponsorChildren's Mercy Hospital Kansas City

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyperfine MRI

    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.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: HyperfineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion, an average of one year

Secondary outcomes

Other outcomes

Sponsors and contacts

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