Ignite Creation Date:
2024-05-06 @ 1:22 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01795989
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2012-07-03
Brief Title:
Use of Specially Designed Pediatric MR Coils on Clinical Scanners
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Novel Coils for Pediatric Musculoskeletal MRI
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 efficacyequivalence of two pediatric 15T coils will be evaluateddemonstrated in two phases Patient safety and image quality will be evaluateddemonstrated in Phase One by collecting images on healthy participants using a combination of the existing commercially available coils and the new coils Clinical efficacyequivalence will be evaluateddemonstrated 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None