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Pediatric Radio Frequency Coils Generic

This study is currently recruiting participants.
Verified May 2013 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 7, 2013
Last verified: May 2013
History of Changes
  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 Intervention Phase
Duchenne Muscular Dystrophy
Musculoskeletal Abnormalities
 Device: RF Coils
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pediatric Radio Frequency Coil Development on Clinical and Research MR Scanners

Resource links provided by NLM:

U.S. FDA Resources

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 Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advances in Radio Frequency for MRI
advances in radio frequency (RF) coil magnetic resonance imaging (MRI)
 Device: RF Coils
RF coil scanning of effectiveness and safety in healthy participants and clinical patients.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
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 7, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2013