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Clinical Trials/NCT06687902
NCT06687902
Active, not recruiting
Not Applicable

Added Value of Digital Breast Tomosynthesis in Characterization of Breast Lesions

Sohag University1 site in 1 country50 target enrollmentOctober 9, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Digital Breast Tomosynthesis
Sponsor
Sohag University
Enrollment
50
Locations
1
Primary Endpoint
Compare DBT with traditional mammography in terms of diagnostic accuracy, sensitivity, and specificity for detecting and differentiating benign and malignant breast lesions
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 9, 2024
End Date
December 6, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shorouk Salaheldien Ali

M.B.B.Ch

Sohag University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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