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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06854887
Enrollment
64
Registered
2025-03-03
Start date
2025-02-28
Completion date
2026-04-01
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digital Breast Tomosynthesis

Brief summary

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

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.

Interventions

DEVICEdigital breast tomosynthesis and mammography

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Recording The breast density in both tomosynthesis and mammography for the main and satellite lesionsbaselineThe breast density according to ACR BIRADS in both tomosynthesis and mammography for the main and satellite lesions
Recording the type of lesion in both tomosynthesis and mammography for the main and satellite lesionsbaselinethe type of lesion (mass , microcalcification , architectural distortion) in both tomosynthesis and mammography for the main and satellite lesions
Recording the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesionsbaselinethe probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions
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 lesionsbaselineThe 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
Recording the tumor histopathology type for the main and satellite lesionsbaselineRecording the tumor histopathology type (ductal, lobular , in situ , others) for the main and satellite lesions

Contacts

Primary ContactSilvia Gamal Rasmy
dsilviajesus@gmail.com+201289374337
Backup ContactEman Abo Elhamd
dr.eman_08@yahoo.com+201001980793

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026