Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT01795989
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.
Looking for future studies?
Notify MeAll sexes
Observational
Cincinnati, Ohio, 45229, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Healthy Participants:
Pediatric Patients:
Exclusion criteria
Pediatric coil for musculoskeletal imaging at 1.5 Tesla for pediatric patients and healthy participants.
Time frame: Day 1
Each participant will be monitored for adverse events during the MRI scan
Time frame: 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.
Children's Hospital Medical Center, Cincinnati
Other
Novel Coils for Pediatric Musculoskeletal MRI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05447078
Healthy Volunteers, Infections
Jackson, Mississippi, United States
View Trial DetailsNCT07513532
Healthy Volunteers
Seattle, Washington, United States
View Trial DetailsNCT07090655
Healthy Volunteers
Brisbane, Australia
View Trial DetailsNCT01915212
Communicable Diseases, DNA Virus Infections
Bethesda, Maryland, United States
View Trial Details