Pediatric Radio Frequency Coils Generic

Duchenne Muscular Dystrophy Clinical Trial

Official title:

Pediatric Radio Frequency Coil Development on Clinical and Research MR Scanners

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01633866
• Other study ID #: 2012-1041
• Status: Active, not recruiting
• Start date: July 2012
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate and optimize advances in radio frequency (RF) coil magnetic resonance imaging (MRI) technology at Cincinnati Children's Hospital Medical Center (CCHMC).

Description:

Pediatric Magnetic resonance (MR) imaging techniques have been limited by the unavailability of specialized radio-frequency (RF) coils for pediatric imaging. Typically, MR coils are designed for general purpose adult imaging and lack the mechanical design, flexibility and high channel count needed for pediatric imaging. Furthermore, pediatric patients are often positioned decubitus or prone rather than supine. This makes coil positioning even more challenging and often results in images with low SNR and poor image quality. Many coils used in clinical practice have fixed dimensions that do not fit within the realm of "one-size fits all," especially for the huge variation found in the pediatric patient population.

MRI coil development and optimization is performed by MR manufacturers and in research laboratories across the world including the Imaging Research Center (IRC) of Cincinnati Children's Hospital and Medical Center (CCHMC). Coil development and refinement involves evaluating the new coils on inert phantoms and then imaging examinations performed on healthy participants and patients. The focus of this study protocol is to evaluate the design and performance of investigational coils on patients and healthy participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Healthy participants:

• Male or Female

• Thermally stable

• Any age

Clinical patients:

• Male or Female

• Thermally stable

• any age

Exclusion Criteria:

Healthy participants & Clinical patients

• Female participants who are pregnant or lactating

• Subjects iwth standard contraindications to MRI

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Musculoskeletal Abnormalities

Locations

Country	Name	City	State
United States	Cincinnati Children's	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as measured by heating and comfort participant response		Day 1
Secondary	MRI Image Quality		2 Weeks Post MRI Scan