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Pediatric Radio Frequency Coils Generic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01633866
Recruitment Status : Active, not recruiting
First Posted : July 4, 2012
Last Update Posted : February 7, 2020
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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).

Condition or disease
Duchenne Muscular Dystrophy Musculoskeletal Abnormalities

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.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pediatric Radio Frequency Coil Development on Clinical and Research MR Scanners
Study Start Date : July 2012
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Advances in Radio Frequency for MRI
advances in radio frequency (RF) coil magnetic resonance imaging (MRI)

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

Secondary Outcome Measures :
  1. MRI Image Quality [ Time Frame: 2 Weeks Post MRI Scan ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01633866

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United States, Ohio
Cincinnati Children's
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
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Principal Investigator: Charles Dumoulin, PhD Children's Hospital Medical Center, Cincinnati
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Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT01633866    
Other Study ID Numbers: 2012-1041
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: August 2019
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Musculoskeletal Abnormalities
Congenital Abnormalities
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked