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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07804147
Enrollment
30
Registered
2026-09-04
Start date
2026-07-12
Completion date
2027-02-01
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

BI-RADS category 3 lesions are considered probably benign findings but generally require short-interval imaging follow-up to document stability. This may result in additional examinations and patient anxiety. The study will investigate the role of digital breast tomosynthesis (DBT) compared with combined ultrasound (US) and digital mammography (DM) in the assessment and reclassification of these lesions, particularly in patients with dense breast tissue. This is a prospective study to be conducted at Sohag University Hospital. The study population will consist of 30 female patients presenting with at least one non-calcified breast lesion initially classified as BI-RADS 3 on standard 2D digital mammography. Patients with breast densities B, C, or D will be eligible, with particular consideration of dense breasts (C and D). All patients will undergo baseline 2D digital mammography, followed by complementary targeted breast ultrasound using a high-resolution linear-array transducer. Ultrasound assessment will include evaluation of lesion shape, orientation, margins, echo pattern, and posterior acoustic features, with a separate US-based BI-RADS assessment. Patients will also undergo digital breast tomosynthesis using standard bilateral craniocaudal and mediolateral oblique views, with reconstruction into 1-mm slices. DBT assessment will include evaluation of lesion margins and assessment for associated architectural distortion or microcalcifications that may not be apparent on 2D mammography. A separate DBT-based BI-RADS assessment will be assigned. The imaging findings will subsequently undergo an integrated assessment. The protocol includes independent assessment of US and DBT findings followed by assignment of a final BI-RADS category based on the combined findings. Reclassification may include downgrading a finding when DBT demonstrates that an apparent mammographic asymmetry represents overlapping normal breast tissue, or upgrading a lesion when suspicious ultrasound features such as non-parallel orientation or angular margins are identified. Diagnostic performance measures, including sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated for US and DBT. Data will be analyzed using SPSS software.

Interventions

None listed

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in BI-RADS classification of breast lesionsthrough study completion, an average of 1 yearThe 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.

Countries

Egypt

Contacts

STUDY_DIRECTORMohamad Zaki Ali, Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026