Low Field Magnetic Resonance Imaging Assessment With Outpatients

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.

Study Overview

• Status: Recruiting
• Conditions: Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound
• Intervention / Treatment: Diagnostic test: Hyperfine MRI

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maura Sien, MS, RT(R); Phone Number: 8163026065; Email: mesien@cmh.edu
• Study Contact Backup: Name: Amie Robinson, MBA, RT(MR)(R); Phone Number: 8163028311; Email: alrobinson@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Children's Mercy Kansas City
      • Contact: Maura Sien; Phone Number: 816-302-6065; Email: mesien@cmh.edu
      • Contact: Amie Robinson; Phone Number: 8163028311; Email: alrobinson@cmh.edu
      • Principal Investigator: Sherwin Chan, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Sherwin Chan, MD PhD, Children's Mercy

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00002266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes