Use of Specially Designed Pediatric MR Coils on Clinical Scanners

NCT01795989 | Completed FDA Device

• 1 other identifier: 2011-2154
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Musculoskeletal Complication

Keywords

Coil; MRI; safety; efficacy; musculoskeletal imaging; MSK

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• MRI Image Quality

  Up to 3 weeks post MRI participant scan

Study Arms (2)

Healthy Volunteers

Research only musculoskeletal (MSK) MRI for healthy volunteers.

Device: 1.5T MRI Elbow Coil

Clinical Efficacy

Clinically indicated musculoskeletal (MSK) MRI with sequences obtained using this pediatric elbow coil.

Device: 1.5T MRI Elbow Coil

Interventions

1.5T MRI Elbow Coil DEVICE

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

Clinical Efficacy; Healthy Volunteers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and pediatric patients seen clinically in Radiology for a standard of care musculoskeletal (MSK) exam

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Study Officials

• Kathleen Emery, M.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: February 21, 2013
• Study Start: November 18, 2011
• Primary Completion: December 29, 2014
• Study Completion: October 4, 2016
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)