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

NCT07804147 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-09-04

No results posted yet for this 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.

Conditions

  • Breast - Female
  • Dense Breast Parenchyma
  • Breast Lesion
  • Digital Mammography

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Principal Investigators

  • Mohamad Zaki Ali, Professor

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-12
Primary Completion
2027-01-01
Completion
2027-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804147 on ClinicalTrials.gov