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NCT Number: NCT06854887

The Added Value of DBT 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

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Key information

Conditions

Digital Breast Tomosynthesis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

digital breast tomosynthesis and mammography

Device

tomosynthesis is 3D image for the breast mammography is 2D image for the breast

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Abo Elhamd

CONTACT

[email protected]

+201001980793

Silvia Gamal Rasmy

CONTACT

[email protected]

+201289374337

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2025
Registry last updated
Mar 3, 2025

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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