Clinical trial NCT01795989: Use of Specially Designed Pediatric MR Coils on Clinical Scanners
Official title: Novel Coils for Pediatric Musculoskeletal MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Musculoskeletal Complication
Keywords: Coil
MRI
safety
efficacy
musculoskeletal imaging
MSK
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and pediatric patients seen clinically in Radiology for a standard of care musculoskeletal (MSK) exam

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.

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.

Primary outcomes:
measure: Number of participants with adverse events as measured by heating and comfort participant response.
timeFrame: Day 1
Secondary outcomes:
measure: MRI Image Quality
timeFrame: Up to 3 weeks post MRI participant scan
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Kathleen Emery, M.D.
role: PRINCIPAL_INVESTIGATOR
References: