Use of Specially Designed Pediatric MR Coils on Clinical Scanners

NCT ID: NCT01795989

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-18
• Study Completion Date: 2016-10-04

Brief Summary

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.

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.

Conditions

Healthy Volunteers; Musculoskeletal Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Volunteers

Research only musculoskeletal (MSK) MRI for healthy volunteers.

1.5T MRI Elbow Coil

Intervention Type: DEVICE

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.

1.5T MRI Elbow Coil

Intervention Type: DEVICE

Pediatric coil for musculoskeletal imaging at 1.5 Tesla for pediatric patients and healthy participants.

Interventions

1.5T MRI Elbow Coil

Pediatric coil for musculoskeletal imaging at 1.5 Tesla for pediatric patients and healthy participants.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Emery, M.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2011-2154

Identifier Type: -

Identifier Source: org_study_id