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ACTIVE NOT RECRUITING
NCT07804147

Evaluation and Reclassification of ( BI-RADS 3) Breast Lesions in Dense Breast

Sponsor: Sohag University

View on ClinicalTrials.gov

Summary

This prospective study aims to compare combined breast ultrasound (US) and digital mammography (DM) with digital breast tomosynthesis (DBT) in the evaluation and reclassification of BI-RADS 3 (probably benign) breast lesions. The study will include 30 female patients with non-calcified breast lesions initially classified as BI-RADS 3 on digital mammography. Patients will undergo complementary targeted breast ultrasound and DBT. The imaging findings will be assessed separately and then integrated to determine the final BI-RADS classification. The study will evaluate whether DBT and combined US with DM can improve characterization and reclassification of BI-RADS 3 lesions, potentially reducing unnecessary short-interval follow-up while identifying lesions requiring further assessment.

Official title: Combined Ultrasound and Digital Mammography Versus Digital Breast Tomosynthesis in the Evaluation and Reclassification of ( BI-RADS 3) Breast Lesions in Dense Breast

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-07-12

Completion Date

2027-02-01

Last Updated

2026-09-04

Healthy Volunteers

No

Locations (1)

Faculty of Medicine Sohag University

Sohag, Sohag Governorate, Egypt