Value of Digital Breast Tomosynthesis in Breast Lesions

November 12, 2024 updated by: Shorouk Salaheldien Ali, Sohag University

Added Value of Digital Breast Tomosynthesis in Characterization of Breast Lesions

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82749
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with breast lesions
Diagnostic test: Digital breast tomosynthesis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2024

Primary Completion (Estimated)

September 10, 2025

Study Completion (Estimated)

December 6, 2025

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med-15-10---5MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

for risk of participant data identification and for privacy concerns

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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