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Clinical Trials in Egypt / NCT07804147
Active, not recruiting Observational

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

NCT07804147 · tracked via the Priya Life Science Egypt tracker
Sponsor
Sohag University
Phase
Observational
Started
2026-07-12
Last updated
2026-09-04

Condition(s) studied

Breast - FemaleDense Breast ParenchymaBreast LesionDigital Mammography

Study 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.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. \- Radiological classification: Patients with at least one non-calcified breast lesion initially classified as BI-RADS 3 (probably benign) on standard 2D digital mammography. 2. \- Breast density: Patients with breast densities B, C, or D are eligible, with particular consideration of dense breasts (C and D). Exclusion Criteria: * Suspicious imaging features: Patients with any lesion demonstrating BI-RADS 4 or 5 characteristics, including spiculated margins, fine linear branching calcifications, or architectural distortion.

Primary outcome measure(s)

  • Change in BI-RADS classification of breast lesions — through study completion, an average of 1 year
    The proportion of initially BI-RADS 3 breast lesions that are reclassified following assessment with digital breast tomosynthesis and complementary breast ultrasound, including downgrading to BI-RADS 2 or upgrading to a higher BI-RADS category based on imaging findings.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Medicine Sohag University Sohag Sohag Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07804147 on ClinicalTrials.gov ↗ ← All trials in Egypt