Three-dimensional Digital Breast Tomosynthesis Versus Digital Mammography

This study aimed to compare the supremacy of (3D) tomosynthesis versus (2D) digital mammography in the diagnosis of benign breast lesions in asymptomatic females.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Three Dimension Asymptomatic Females Benign Breast Lesions Diagnosis Digital Mammography Digital Tomosynthesis Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year and older

Sex eligibility

Female

Study type

Observational

Primary location

General Authority for Teaching Hospitals and Institutes

Cairo, Egypt

About this study

Most of the breast lesions are benign, but much concern is given to malignant lesions because breast cancer is the most common malignancy in women.

Mammography is the only study for screening in asymptomatic patients, and it is the initial imaging study in the diagnosis of symptomatic patients, with a sensitivity for suspicious lesions of 86% and a specificity of 57%.

In recent years, a significant effort has been expended to develop new approaches to breast imaging, one of which is the use of digital breast tomosynthesis (DBT), which is a pseudo three-dimensional digital mammography system that produces a series of thin-section reconstructed images from low-dose X-ray projections at multiple angles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with benign breast lesions.

Exclusion criteria

Pregnant and lactating female.
Patients who refuse to fill the consent form.

Treatment and study plan

Three-dimensional Digital Breast Tomosynthesis

Device

Patients underwent three-dimensional digital breast tomosynthesis.

Two-dimensional Digital Mammography

Device

Patients underwent two-dimensional digital mammography

Primary outcomes

Correlation between imaging findings and the final diagnosis

Time frame: 6 months post-procedure

Correlation between imaging findings and the final diagnosis was calculated.

Sponsors and collaborators

Lead sponsor

The General Authority for Teaching Hospitals and Institutes

Network

Registry information

Official study title

Three-dimensional Digital Breast Tomosynthesis Versus Digital Mammography: Which Get the Supremacy in Diagnosis of Benign Breast Lesions in Asymptomatic Females

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 28, 2025
Registry last updated: Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed