Value of Digital Breast Tomosynthesis in Breast Lesions

Added Value of Digital Breast Tomosynthesis in Characterization of Breast Lesions

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06687902

Enrollment

Registered

2024-11-14

Start date

2024-10-09

Completion date

2025-12-06

Last updated

2024-11-14

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

Conditions

Digital Breast Tomosynthesis

Brief summary

The aim of the study is to evaluate the added value of digital breast tomosynthesis (DBT) in the characterization of breast lesions.

Detailed description

All patients enrolled in the study will undergo both 2D digital mammography and digital breast tomosynthesis (DBT), using standardized protocols. The DM plus DBT acquisition commonly referred to as combo mode , that has shown an improvement in specificity and sensitivity , but at approximately doubling of the radiation dose . This approach will provide a consistent framework for evaluating the diagnostic capabilities of both techniques in characterizing breast masses.

Interventions

DIAGNOSTIC_TESTDigital breast tomosynthesis

In digital breast tomosynthesis (DBT), images are acquired using a specialized X-ray tube that moves in an arc around the breast. This technique captures multiple low-dose images from various angles, typically within a 15° to 60° range. These images are then reconstructed into 1-mm slices to create a 3D representation of the breast, allowing for detailed layer-by-layer evaluation. The number of images acquired varies depending on the size of the breast and the specifications of the equipment but generally ranges from 10 to 25 projections, captured within a few seconds.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

1. Patients with mammographic breast lesions of BIRADS III, IV. 2. Dense breast in patients with complaints (BIRADS 0) which needed further assessment.

Exclusion criteria

1. Pregnant females to avoid the hazards of ionizing radiation to the fetus. 2. Patients with known metastatic breast cancer.

Design outcomes

Primary

Measure	Time frame
Compare DBT with traditional mammography in terms of diagnostic accuracy, sensitivity, and specificity for detecting and differentiating benign and malignant breast lesions	1 hour

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026