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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
  Purpose

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).


Condition Phase
Duchenne Muscular Dystrophy
Musculoskeletal Abnormalities
Phase 1
Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pediatric Radio Frequency Coil Development on Clinical and Research MR Scanners

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Number of participants with adverse events as measured by heating and comfort participant response [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MRI Image Quality [ Time Frame: 2 Weeks Post MRI Scan ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Advances in Radio Frequency for MRI
advances in radio frequency (RF) coil magnetic resonance imaging (MRI)

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633866

Locations
United States, Ohio
Cincinnati Children's Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kansie E Somers, M.A.    513-636-9403    kansie.somers@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Charles Dumoulin, PhD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01633866     History of Changes
Other Study ID Numbers: 2012-1041
Study First Received: June 21, 2012
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Musculoskeletal Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Muscular Diseases
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on November 23, 2014