Use of Specially Designed Pediatric MR Coils on Clinical Scanners
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2011 |
| End Date: | December 2016 |
Novel Coils for Pediatric Musculoskeletal MRI
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.
(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.
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.
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.
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.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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