Three-dimensional Digital Breast Tomosynthesis Versus Digital Mammography

NCT07145892 | Completed

• 1 other identifier: HD000217
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Correlation between imaging findings and the final diagnosis

  Correlation between imaging findings and the final diagnosis was calculated.

  6 months post-procedure

Study Arms (3)

Group I

Categorized 130 women aged from 30 to 40 years.

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

Group II

Categorized 115 women aged from 40 to 50 years.

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

Group III

Categorized 10 females aged above 50 years.

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

Interventions

Three-dimensional Digital Breast Tomosynthesis DEVICE

Patients underwent three-dimensional digital breast tomosynthesis.

Group I; Group II; Group III

Two-dimensional Digital Mammography DEVICE

Patients underwent two-dimensional digital mammography

Group I; Group II; Group III

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: Women with benign breast lesions
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study was conducted on patients referred to the Diagnostic Radiology Department at Damanhur Educational Hospital and Tanta University.

You may qualify if:

• \- Women with benign breast lesions.

You may not qualify if:

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

Sponsors & Collaborators

• The General Authority for Teaching Hospitals and Institutes: lead

Study Sites (1)

General Authority for Teaching Hospitals and Institutes

Cairo, Egypt

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Diagnostic Radiology, Damnhour National Medical Institute

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: June 1, 2024
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)