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OpenTrials
Completed

NCT Number: NCT01795989

Use of Specially Designed Pediatric MR Coils on Clinical Scanners

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1.5T MRI Elbow Coil

Device

Pediatric coil for musculoskeletal imaging at 1.5 Tesla for pediatric patients and healthy participants.

Primary outcomes

  1. Number of participants with adverse events as measured by heating and comfort participant response.

    Time frame: Day 1

    Each participant will be monitored for adverse events during the MRI scan

Secondary outcomes

  1. MRI Image Quality

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Novel Coils for Pediatric Musculoskeletal MRI

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Feb 21, 2013
Registry last updated
Sep 16, 2020

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.

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