Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT07247435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of CT in Tetralogy of Fallot Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical anomalies identification', 'timeFrame': '3 years', 'description': 'Identification cardiac and extra-cardiac anatomical anomalies'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac CT TOF']}, 'referencesModule': {'references': [{'pmid': '12084585', 'type': 'BACKGROUND', 'citation': 'Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.'}, {'pmid': '18344706', 'type': 'BACKGROUND', 'citation': 'Freeman SB, Bean LH, Allen EG, Tinker SW, Locke AE, Druschel C, Hobbs CA, Romitti PA, Royle MH, Torfs CP, Dooley KJ, Sherman SL. Ethnicity, sex, and the incidence of congenital heart defects: a report from the National Down Syndrome Project. Genet Med. 2008 Mar;10(3):173-80. doi: 10.1097/GIM.0b013e3181634867.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the role of MSCT in diagnosis and surgical planning in tetralogy of Fallot cases.', 'detailedDescription': 'Role of Computed tomography (CT) : CT has become an indispensable imaging modality in the comprehensive evaluation and management of Tetralogy of Fallot (ToF). While echocardiography remains the initial diagnostic tool, CT offers unparalleled spatial resolution and the ability to generate high-quality, three-dimensional reconstructions of both intracardiac and extracardiac anatomy. This is particularly valuable for identifying associated anomalies such as major aortopulmonary collateral arteries (MAPCAs), anomalous coronary artery origins, and variations in pulmonary artery branching patterns that can significantly influence surgical decision-making. Preoperatively, CT enables precise assessment of the severity and extent of right ventricular outflow tract obstruction, ventricular septal defect morphology, and the relationship of the overriding aorta to the interventricular septum.\n\nOverall, CT complements other imaging modalities by providing a fast, accurate, and comprehensive anatomical roadmap that guides surgical planning, informs long-term follow-up, and aids in the early detection of complications. Its role is particularly pronounced in complex and syndromic cases of ToF, where anatomical variations are more common and precise preoperative mapping is critical for successful outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with tetralogy of Fallot either syndromic or non syndromic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- patients aged 1 day up to 12 years Confirmed diagnosis of tetralogy of Fallot. Patients with tetralogy of Fallot as apart from genetic syndrome.\n\nExclusion Criteria:\n\n* Patients with other isolated congenital heart anomalies Previously operated cases of tetralogy of Fallot.'}, 'identificationModule': {'nctId': 'NCT07247435', 'briefTitle': 'Role of CT in Tetralogy of Fallot Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Computed Tomography in Diagnosis of Syndromic and Non Syndromic Tetralogy of Fallot', 'orgStudyIdInfo': {'id': 'Cardiac CT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Computed tomography', 'type': 'DEVICE', 'description': 'Radiological device'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Benyamin Gaballah', 'role': 'CONTACT', 'email': 'benyaminadel99@gmail.com', 'phone': '01025303267'}, {'name': 'Hassan Megaly, Professor', 'role': 'CONTACT', 'phone': '01006209584'}], 'overallOfficials': [{'name': 'WAGEEH Abd el-hafeez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RD', 'investigatorFullName': 'Benyamin Adel Abdullah Gaballah', 'investigatorAffiliation': 'Assiut University'}}}}