The Added Value of DBT Over Mammography in Local Tumor Staging in Patients With BIRADS 4 or 5 Lesions

Not yet recruiting

• Conditions: Digital Breast Tomosynthesis

• Registration Number: NCT06854887
• Lead Sponsor: Assiut University

Brief Summary

Compare the diagnostic accuracy of tomosynthesis with 2D mammography in cases with suspected BI-RADS 4 or 5 to determine its potential benefit for staging

Detailed Description

Digital breast tomosynthesis (DBT) is a promising 3D imaging technique for breast imaging that use in breast cancer detection. it acquires reconstructed volume data , the data is reconstructed secondarily in mammary slices from several radiographs acquired from different angles of view (-15◦ to +15◦ for Fuji). It theoretically improves the sensitivity of detection by enabling enhanced delimitation of the lesion margins, and the specificity by avoiding the problem of glandular superimposition, By separating overlapping breast tissues \& it enhances detection of abnormalities located in different planes. DBT has higher breast cancer detection rates and lower recall rates compared with digital mammography (DM). There is also evidence of the diagnostic efficacy of DBT in women with clinical symptoms and women with screen-detected findings who have been recalled for work-up. Consequently, recommendations have been made about the role of DBT in screening asymptomatic women according to their risk levels, in evaluation of symptomatic women, and in work-up of suspicious DM findings. The main objective of this study was to compare tomosynthesis with 2D mammography in cases with suspected BI-RADS 4 or 5 anomalies, to determine its potential benefit for staging.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study Start: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Primary Completion: 2026-03-29
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. BI-RADS 4 OR 5 LESION that pathologically proved to be breast cancer.
2. No history of previous operations
3. No history of chemotherapy or radiotherapy

Exclusion Criteria

1. BI-RADS 1 ,2,3 lesions
2. History of previous operation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recording The breast density in both tomosynthesis and mammography for the main and satellite lesions	baseline	The breast density according to ACR BIRADS in both tomosynthesis and mammography for the main and satellite lesions
Recording the type of lesion in both tomosynthesis and mammography for the main and satellite lesions	baseline	the type of lesion (mass , microcalcification , architectural distortion) in both tomosynthesis and mammography for the main and satellite lesions
Recording the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions	baseline	the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions
Recording the location of the tumor within the mammary quadrants and the depth of the tumor in both tomosynthesis and mammography for the main and satellite lesions	baseline	The location of the tumor within the mammary quadrants (upper , lower , outer , inner ) and the depth (anterior-middle-posterior) of the tumor in both tomosynthesis and mammography for the main and satellite lesions
Recording the tumor histopathology type for the main and satellite lesions	baseline	Recording the tumor histopathology type (ductal, lobular , in situ , others) for the main and satellite lesions