Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 2:05 PM
Study NCT ID:
NCT01633866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-16
First Post:
2012-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Radio Frequency Coils Generic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2012-06-21', 'studyFirstSubmitQcDate': '2012-07-02', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events as measured by heating and comfort participant response', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'MRI Image Quality', 'timeFrame': '2 Weeks Post MRI Scan'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Magnetic Resonance Imaging'], 'conditions': ['Duchenne Muscular Dystrophy', 'Musculoskeletal Abnormalities']}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': '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.\n\nMRI 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy participants:\n\n* Male or Female\n* Thermally stable\n* Any age\n\nClinical patients:\n\n* Male or Female\n* Thermally stable\n* any age\n\nExclusion Criteria:\n\nHealthy participants \\& Clinical patients\n\n* Female participants who are pregnant or lactating\n* Subjects iwth standard contraindications to MRI'}, 'identificationModule': {'nctId': 'NCT01633866', 'briefTitle': 'Pediatric Radio Frequency Coils Generic', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Pediatric Radio Frequency Coil Development on Clinical and Research MR Scanners', 'orgStudyIdInfo': {'id': '2012-1041'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advances in Radio Frequency for MRI', 'description': 'advances in radio frequency (RF) coil magnetic resonance imaging (MRI)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Charles Dumoulin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}