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NCT Number: NCT06687902

Value of Digital Breast Tomosynthesis in Breast Lesions

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Digital Breast Tomosynthesis

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University

Sohag, 82749, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Digital breast tomosynthesis

Diagnostic Test

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.

Primary outcomes

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

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Added Value of Digital Breast Tomosynthesis in Characterization of Breast Lesions

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

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.

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