Use of Specially Designed Pediatric MR Coils on Clinical Scanners

Novel Coils for Pediatric Musculoskeletal MRI

The purpose of this research study is to test the use of new Magnetic Resonance Imaging (MRI) coils. An MRI takes pictures of body parts using a large magnet and a computer. A coil is the part of the MRI system that collects data to make the MR images. The investigators have designed, developed, and built two child-sized coils to use when imaging elbows, wrists, knees, and ankles. These new coils will be better suited to fit infants through teenagers rather than the conventional coils used which were created for adults These MRI coils have not been approved by the US Food and Drug Administration (FDA) and are considered investigational devices.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Musculoskeletal Complication
• Intervention / Treatment: Device: 1.5T MRI Elbow Coil

Detailed Description

The safety and the clinical efficacy/equivalence of two pediatric 1.5T coils will be evaluated/demonstrated in two phases. Patient safety and image quality will be evaluated/demonstrated in Phase One by collecting images on healthy participants using a combination of the existing commercially available coils and the new coils. Clinical efficacy/equivalence will be evaluated/demonstrated in Phase Two by collecting standard MRI exams in pediatric patients. In Phase Two, the imaging data for a given patient will be collected by one of the two following scenarios : 1) the clinically ordered exams will be completed using a combination of the existing commercially available coils and new coil, with the images from each directly compared, or 2) the clinically ordered scans will be collected using one of the new coils and the images compared to historical de-identified MR exam, age and gender matched patient data (which were acquired using the existing commercially available coils). Results of Phase One will be reported to the IRB. Phase Two will not begin until the IRB has reviewed the results of Phase One and approved the commencement of Phase Two.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and pediatric patients seen clinically in Radiology for a standard of care musculoskeletal (MSK) exam

Description

Inclusion Criteria:

Healthy Participants:

• Male or female
• Age: Old enough to participate in an MR study without sedation (typically greater than 5-6 years old)

Pediatric Patients:

• Male or female
• Sent for elbow MR or superficial/small parts musculoskeletal MR imaging.
• Age: any age

Exclusion Criteria:

• Female participants who are pregnant or lactating (verbal pregnancy screens will be given for all females of child bearing potential prior to the MRI).
• Subjects with standard contraindications to MRI.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; Research only musculoskeletal (MSK) MRI for healthy volunteers.	Device: 1.5T MRI Elbow Coil; Pediatric coil for musculoskeletal imaging at 1.5 Tesla for pediatric patients and healthy participants.
Clinical Efficacy; Clinically indicated musculoskeletal (MSK) MRI with sequences obtained using this pediatric elbow coil.	Device: 1.5T MRI Elbow Coil; Pediatric coil for musculoskeletal imaging at 1.5 Tesla for pediatric patients and healthy participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events as measured by heating and comfort participant response.	Each participant will be monitored for adverse events during the MRI scan	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI Image Quality	The following measures will be individually evaluated on 3-point scale: Overall image quality, Image uniformity overall, and Signal to Noise.	Up to 3 weeks post MRI participant scan

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Kathleen Emery, M.D., Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2011
• Primary Completion (Actual): December 29, 2014
• Study Completion (Actual): October 4, 2016

Study Registration Dates

• First Submitted: July 3, 2012
• First Submitted That Met QC Criteria: February 19, 2013
• First Posted (Estimate): February 21, 2013

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: MRI; safety; efficacy; MSK; Coil; musculoskeletal imaging
• Other Study ID Numbers: 2011-2154

Drug and device information, study documents

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