- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06196216
Breast Lesion in CT Chest
December 24, 2023 updated by: Abeer Mohamed Ali, Assiut University
Referal Features of Incidental Breast Masses in Chest CT
The aims of this study are To evaluate the CT features of incidental breast lesions on chest CT and subsequently suggest useful criteria for referral to a specialized breast unit.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Enhanced chest CT examination reports containing the key word 'breast' well be reviewed retrospectively.
Patients who had incidental breast lesion and were referred to a specialized breast unit and then underwent pathological confirmation well be included.
Finally, 100 patients well be enrolled.
Two radiologists well evaluate lesion characteristics including; size, shape, margins and enhancement.
The correlations between the CT features and pathologies well be evaluated and the diagnostic accuracy of CT features in various combinations well be assessed.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt
- Assiut University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
adult female patients who underwent enhanced CT chest that incidentally revealed breast lesion(s) then referred to a specialized breast centre and had histopathological diagnosis.
Description
Inclusion Criteria:
- Inclusion criteria are patients who ex hibited incidental breast lesion(s) on enhanced chest CT and were referred to a specialized breast unit for assessment and then underwent pathological confirmation.
Exclusion Criteria:
- -Patients with known breast dis ease.
- Previous history of breast cancer or breast surgery.
- Patients who had undergone only non-enhanced CT examination.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
detect useful CT criteria of breast lesions subsequently suggest criteria for referral to a specialized breast unit
Time Frame: 3years
|
detect useful CT criteria of breast lesions subsequently suggest criteria for referral to a specialized breast unit
|
3years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Abo-Elhassan Hassib Mohamed, Associate professor, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
- Harish MG, Konda SD, MacMahon H, Newstead GM. Breast lesions incidentally detected with CT: what the general radiologist needs to know. Radiographics. 2007 Oct;27 Suppl 1:S37-51. doi: 10.1148/rg.27si075510.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2027
Study Registration Dates
First Submitted
December 24, 2023
First Submitted That Met QC Criteria
December 24, 2023
First Posted (Actual)
January 9, 2024
Study Record Updates
Last Update Posted (Actual)
January 9, 2024
Last Update Submitted That Met QC Criteria
December 24, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- CT chest in breast cancer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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