Three-dimensional Digital Breast Tomosynthesis Versus Digital Mammography

The General Authority for Teaching Hospitals and Institutes

Status: Completed

Conditions: Diagnosis; Benign Breast Lesions; Digital Tomosynthesis; Asymptomatic Females; Three Dimension; Digital Mammography

Treatments: Device: Two-dimensional Digital Mammography; Device: Three-dimensional Digital Breast Tomosynthesis

Study type: Observational

Funder types: NETWORK

Identifiers

NCT07145892

HD000217

Details and patient eligibility

About

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

Full description

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.

Enrollment: 255 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- Women with benign breast lesions.

Exclusion criteria

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

Trial design

255 participants in 3 patient groups

Group I

Description:

Categorized 130 women aged from 30 to 40 years.

Treatment:

Device: Three-dimensional Digital Breast Tomosynthesis

Device: Two-dimensional Digital Mammography

Group II

Description:

Categorized 115 women aged from 40 to 50 years.

Treatment:

Device: Three-dimensional Digital Breast Tomosynthesis

Device: Two-dimensional Digital Mammography

Group III

Description:

Categorized 10 females aged above 50 years.

Treatment:

Device: Three-dimensional Digital Breast Tomosynthesis

Device: Two-dimensional Digital Mammography