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Pediatric Radio Frequency Coils Generic

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01633866
First received: June 21, 2012
Last updated: May 2, 2014
Last verified: May 2014

June 21, 2012
May 2, 2014
July 2012
June 2017   (final data collection date for primary outcome measure)
Number of participants with adverse events as measured by heating and comfort participant response [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01633866 on ClinicalTrials.gov Archive Site
MRI Image Quality [ Time Frame: 2 Weeks Post MRI Scan ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pediatric Radio Frequency Coils Generic
Pediatric Radio Frequency Coil Development on Clinical and Research MR Scanners

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).

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Healthy participants will be recruited by word-of-mouth, generally from within CCHMC.The healthy participants could include children of faculty or staff members of CCHMC.Because the healthy participants could include children of faculty or staff members, recruitment will be consistent with CCHMC Research Policy.Patients will be recruited at the time of their scheduled clinical scan.We are only using these participants to evaluate the safety and feasibility of the use of the new coils in our patient population.For this reason, we will not focus on the demographics of the participants.However, we will attempt to obtain a broad anatomic size range to match that of the patient population for which the coils were developed.

  • Duchenne Muscular Dystrophy
  • Musculoskeletal Abnormalities
Not Provided
Advances in Radio Frequency for MRI
advances in radio frequency (RF) coil magnetic resonance imaging (MRI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
June 2017
June 2017   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
United States
 
NCT01633866
2012-1041
Yes
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Not Provided
Principal Investigator: Charles Dumoulin, PhD Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP