Low Field Magnetic Resonance Imaging Assessment With Outpatients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperfine MRI.
- Who it may be relevant to
- Registry conditions: Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound. Basic parameters: 0 years — 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test 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 measures
- Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US [Time frame: Through study completion, an average of 3 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Children's Mercy Kansas City — Kansas City
Identifiers
NCT: NCT05582785 · STUDY00002266