Cardiac CT TOFNCT07247435
Role of CT in Tetralogy of Fallot Diagnosis
An observational study of Cardiac CT TOF, run by Assiut University.
Trial summary
To evaluate the role of MSCT in diagnosis and surgical planning in tetralogy of Fallot cases. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Cardiac CT TOF
- What is being tested?
- Computed tomography
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2025to 15 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with tetralogy of Fallot either syndromic or non syndromic
Who may be able to join
- patients aged 1 day up to 12 years Confirmed diagnosis of tetralogy of Fallot. Patients with tetralogy of Fallot as apart from genetic syndrome.
Who cannot join
- Patients with other isolated congenital heart anomalies Previously operated cases of tetralogy of Fallot.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hassan Megaly, Professor contact
About this study
Official title: Role of Computed Tomography in Diagnosis of Syndromic and Non Syndromic Tetralogy of Fallot
To evaluate the role of MSCT in diagnosis and surgical planning in tetralogy of Fallot cases.
Read the 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.
- Conditions
- Cardiac CT TOF
- Being tested
- Computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomographyDevice
Radiological device
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical anomalies identification
Identification cardiac and extra-cardiac anatomical anomalies
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 Nov 2025 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac CT TOFStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benyamin Adel Abdullah Gaballah, Assiut University
- Investigators
- WAGEEH Abd el-hafeez, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247435
- Sponsor's protocol ID
- Cardiac CT
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12084585Freeman 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.
PubMed 18344706
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Computed Tomography in Diagnosis of Syndromic and Non Syndromic Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT07247435
- Acronym / sponsor ID
- Cardiac CT
- Conditions
- Cardiac CT TOF
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with tetralogy of Fallot either syndromic or non syndromic
Key inclusion criteria (1 listed)
- patients aged 1 day up to 12 years Confirmed diagnosis of tetralogy of Fallot. Patients with tetralogy of Fallot as apart from genetic syndrome.
Key exclusion criteria (1 listed)
- Patients with other isolated congenital heart anomalies Previously operated cases of tetralogy of Fallot.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomographyRadiological device | Device | – |
Primary outcome
Anatomical anomalies identification
Time frame: 3 years
Identification cardiac and extra-cardiac anatomical anomalies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 12084585Hoffman 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.
- Background: PubMed 18344706Freeman 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.
Related trials for Cardiac CT TOF
RecruitingObservational study
Repaired Tetralogy of Fallot Italian Registry
Tetralogy of Fallot, Cardiac Death, Sudden
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hassan Megaly, Professor contact
WAGEEH Abd el-hafeez principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac CT TOF, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benyamin Gaballah (01025303267, benyaminadel99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical anomalies identification (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07247435, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.