The Added Value of DBT Over Mammography in Local Tumor Staging in Patients With BIRADS 4 or 5 Lesions

February 28, 2025 updated by: Silvia Gamal Rasmy, Assiut University

The Added Value of Digital Breast Tomosynthesis Over Mammography in Local Tumor Staging in Patients With BIRADS 4 or 5 Lesions

Compare the diagnostic accuracy of tomosynthesis with 2D mammography in cases with suspected BI-RADS 4 or 5 to determine its potential benefit for staging

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Digital breast tomosynthesis (DBT) is a promising 3D imaging technique for breast imaging that use in breast cancer detection. it acquires reconstructed volume data , the data is reconstructed secondarily in mammary slices from several radiographs acquired from different angles of view (-15◦ to +15◦ for Fuji). It theoretically improves the sensitivity of detection by enabling enhanced delimitation of the lesion margins, and the specificity by avoiding the problem of glandular superimposition, By separating overlapping breast tissues & it enhances detection of abnormalities located in different planes. DBT has higher breast cancer detection rates and lower recall rates compared with digital mammography (DM). There is also evidence of the diagnostic efficacy of DBT in women with clinical symptoms and women with screen-detected findings who have been recalled for work-up. Consequently, recommendations have been made about the role of DBT in screening asymptomatic women according to their risk levels, in evaluation of symptomatic women, and in work-up of suspicious DM findings. The main objective of this study was to compare tomosynthesis with 2D mammography in cases with suspected BI-RADS 4 or 5 anomalies, to determine its potential benefit for staging.

Study Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This study included patients with BIRADS 4 or 5 lesions who pathologically proved to be breast cancer by TCNB

Description

Inclusion Criteria:

  1. BI-RADS 4 OR 5 LESION that pathologically proved to be breast cancer.
  2. No history of previous operations
  3. No history of chemotherapy or radiotherapy

Exclusion Criteria:

  1. BI-RADS 1 ,2,3 lesions
  2. History of previous operation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recording The breast density in both tomosynthesis and mammography for the main and satellite lesions
Time Frame: baseline
The breast density according to ACR BIRADS in both tomosynthesis and mammography for the main and satellite lesions
baseline
Recording the type of lesion in both tomosynthesis and mammography for the main and satellite lesions
Time Frame: baseline
the type of lesion (mass , microcalcification , architectural distortion) in both tomosynthesis and mammography for the main and satellite lesions
baseline
Recording the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions
Time Frame: baseline
the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions
baseline
Recording the location of the tumor within the mammary quadrants and the depth of the tumor in both tomosynthesis and mammography for the main and satellite lesions
Time Frame: baseline
The location of the tumor within the mammary quadrants (upper , lower , outer , inner ) and the depth (anterior-middle-posterior) of the tumor in both tomosynthesis and mammography for the main and satellite lesions
baseline
Recording the tumor histopathology type for the main and satellite lesions
Time Frame: baseline
Recording the tumor histopathology type (ductal, lobular , in situ , others) for the main and satellite lesions
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

February 28, 2025

Primary Completion (Estimated)

March 29, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • DBT &Mammography in BIRADS 4-5

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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