Use of Specially Designed Pediatric MR Coils on Clinical Scanners

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT01795989

Collaborator

(none)

Enrollment

Location

58.5

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers Musculoskeletal Complication	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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Novel Coils for Pediatric Musculoskeletal MRI

Actual Study Start Date :

Nov 18, 2011

Actual Primary Completion Date :

Dec 29, 2014

Actual Study Completion Date :

Oct 4, 2016

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events as measured by heating and comfort participant response. [Day 1]
Each participant will be monitored for adverse events during the MRI scan

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.