Role of CT in Tetralogy of Fallot Diagnosis | NCT07247435

Studies
Role of CT in Tetralogy of Fallot Diagnosis

NCT07247435

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Nov 25, 2025Actual

Enrollment

37Estimated

Phase

Not provided

Conditions

Cardiac CT TOF

Interventions

Computed tomography

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2025Estimated

Primary Completion Date

Sep 15, 2028Estimated

Completion Date

Sep 15, 2028Estimated

First Submitted Date

Sep 24, 2025

First Submission Date that Met QC Criteria

Nov 21, 2025

First Posted Date

Nov 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2025

Last Update Posted Date

Nov 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the role of MSCT in diagnosis and surgical planning in tetralogy of Fallot cases.

Detailed Description

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.

Overall, 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computed tomography	Device	Radiological device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anatomical anomalies identification	Identification cardiac and extra-cardiac anatomical anomalies	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- patients aged 1 day up to 12 years Confirmed diagnosis of tetralogy of Fallot. Patients with tetralogy of Fallot as apart from genetic syndrome.

Exclusion Criteria:

Patients with other isolated congenital heart anomalies Previously operated cases of tetralogy of Fallot.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Years

Standard Ages

Child

Study Population

Children with tetralogy of Fallot either syndromic or non syndromic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benyamin Gaballah	Contact	01025303267		benyaminadel99@gmail.com
Hassan Megaly, Professor	Contact	01006209584

Overall Officials

Name	Affiliation	Role
WAGEEH Abd el-hafeez	Assiut University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12084585	Background	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.
18344706	Background	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.

ID	Term
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis