Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients
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ClinicalTrials.gov Identifier: NCT04629469 |
Recruitment Status :
Recruiting
First Posted : November 16, 2020
Last Update Posted : August 9, 2021
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Condition or disease | Intervention/treatment | Phase |
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Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound | Diagnostic Test: Hyperfine MRI | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients |
Actual Study Start Date : | October 1, 2020 |
Estimated Primary Completion Date : | July 2025 |
Estimated Study Completion Date : | December 2025 |

Arm | Intervention/treatment |
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Experimental: Hyperfine
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.
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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. |
- Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US [ Time Frame: Through study completion, an average of one year ]Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US

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Ages Eligible for Study: | 0 Days to 22 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629469
Contact: Maura Sien, MS,RT(R) | 8163026065 | mesien@cmh.edu | |
Contact: Amie Robinson, BSRT(R)(MR) | 8163028311 | alrobinson@cmh.edu |
United States, Missouri | |
Children's Mercy Hospital | Recruiting |
Kansas City, Missouri, United States, 64108 | |
Contact: Maura Sien, BS,RT(R) 816-302-6065 mesien@cmh.edu | |
Contact: Amie Robinson, BS,RT(R)(MR) 8163028311 alrobinson@cmh.edu | |
Principal Investigator: Sherwin Chan, MD,PHD |
Principal Investigator: | Sherwin Chan, MD,PHD | Children's Mercy Kansas City |
Responsible Party: | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT04629469 |
Other Study ID Numbers: |
STUDY00001356 |
First Posted: | November 16, 2020 Key Record Dates |
Last Update Posted: | August 9, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |