Healthy Volunteers Clinical Trial
Official title:
Novel Coils for Pediatric Musculoskeletal MRI
NCT number | NCT01795989 |
Other study ID # | 2011-2154 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 18, 2011 |
Est. completion date | October 4, 2016 |
Verified date | September 2020 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 4, 2016 |
Est. primary completion date | December 29, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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