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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04629469
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : August 15, 2022
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

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.

Condition or disease Intervention/treatment Phase
Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound Diagnostic Test: Hyperfine MRI Not Applicable

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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 :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Days to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Contacts
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Contact: Maura Sien, MS,RT(R) 8163026065 mesien@cmh.edu
Contact: Amie Robinson, BSRT(R)(MR) 8163028311 alrobinson@cmh.edu

Locations
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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         
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
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Principal Investigator: Sherwin Chan, MD,PHD Children's Mercy Kansas City
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 15, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes