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

NCT07804147 | Active Not Recruiting

• 1 other identifier: Soh-Med-26-7-16MS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast; dense breast; probably benign breast lesions; BIRADs 3; breast lesions reassessment

Outcome Measures

Primary Outcomes (1)

• Change in BI-RADS classification of breast lesions

  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.

  through study completion, an average of 1 year

Study Arms (1)

BI-RADS 3 Breast Lesion Cohort

Female patients with at least one non-calcified breast lesion initially classified as BI-RADS 3 (probably benign) on digital mammography. Participants undergo complementary targeted breast ultrasound and digital breast tomosynthesis for evaluation and reclassification of the lesion.

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 30 female patients presenting with at least one non-calcified breast lesion initially classified as BI-RADS 3 (probably benign) on standard 2D digital mammography. Patients with breast densities B, C, or D will be included, with particular consideration of dense breasts (C and D). All eligible participants will undergo complementary targeted breast ultrasound and digital breast tomosynthesis for lesion evaluation and BI-RADS reclassification.

You may qualify if:

• \- Radiological classification: Patients with at least one non-calcified breast lesion initially classified as BI-RADS 3 (probably benign) on standard 2D digital mammography.
• \- Breast density: Patients with breast densities B, C, or D are eligible, with particular consideration of dense breasts (C and D).

You may not qualify if:

• Suspicious imaging features:
• Patients with any lesion demonstrating BI-RADS 4 or 5 characteristics, including spiculated margins, fine linear branching calcifications, or architectural distortion.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine Sohag University

Sohag, Sohag Governorate, 0000, Egypt

Location

Study Officials

• Mohamad Zaki Ali, Professor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiology resident

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 4, 2026
• Study Start: July 12, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)