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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings