Three-dimensional Digital Breast Tomosynthesis Versus Digital Mammography

NCT ID: NCT07145892

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-05-29

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group I

Categorized 130 women aged from 30 to 40 years.

Three-dimensional Digital Breast Tomosynthesis

Intervention Type DEVICE

Patients underwent three-dimensional digital breast tomosynthesis.

Two-dimensional Digital Mammography

Intervention Type DEVICE

Patients underwent two-dimensional digital mammography

Group II

Categorized 115 women aged from 40 to 50 years.

Three-dimensional Digital Breast Tomosynthesis

Intervention Type DEVICE

Patients underwent three-dimensional digital breast tomosynthesis.

Two-dimensional Digital Mammography

Intervention Type DEVICE

Patients underwent two-dimensional digital mammography

Group III

Categorized 10 females aged above 50 years.

Three-dimensional Digital Breast Tomosynthesis

Intervention Type DEVICE

Patients underwent three-dimensional digital breast tomosynthesis.

Two-dimensional Digital Mammography

Intervention Type DEVICE

Patients underwent two-dimensional digital mammography

Interventions

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Three-dimensional Digital Breast Tomosynthesis

Patients underwent three-dimensional digital breast tomosynthesis.

Intervention Type DEVICE

Two-dimensional Digital Mammography

Patients underwent two-dimensional digital mammography

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Women with benign breast lesions.

Exclusion Criteria

* Pregnant and lactating female.
* Patients who refuse to fill the consent form.
Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The General Authority for Teaching Hospitals and Institutes

NETWORK

Sponsor Role lead

Responsible Party

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Hekmat Samir Baumey

Lecturer of Diagnostic Radiology, Damnhour National Medical Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Authority for Teaching Hospitals and Institutes

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HD000217

Identifier Type: -

Identifier Source: org_study_id

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