Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound
Conditions
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.
Interventions
DIAGNOSTIC_TESTHyperfine 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.
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 22 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US | Through study completion, an average of one year | Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US |
Countries
United States
Contacts
Primary ContactMaura Sien, MS,RT(R)
Outcome results
None listed