The Added Value of DBT Over Mammography in Local Tumor Staging in Patients With BIRADS 4 or 5 Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: digital breast tomosynthesis and mammography.
- Who it may be relevant to
- Registry conditions: Digital Breast Tomosynthesis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Added Value of Digital Breast Tomosynthesis Over Mammography in Local Tumor Staging in Patients With BIRADS 4 or 5 Lesions
Overview
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
- Device digital breast tomosynthesis and mammography
tomosynthesis is 3D image for the breast mammography is 2D image for the breast
Primary outcome measures
- Recording The breast density in both tomosynthesis and mammography for the main and satellite lesions [Time frame: baseline]
- Recording the type of lesion in both tomosynthesis and mammography for the main and satellite lesions [Time frame: baseline]
- Recording the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions [Time frame: 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]
- Recording the tumor histopathology type for the main and satellite lesions [Time frame: baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Mariscotti G, Durando M, Houssami N, Fasciano M, Tagliafico A, Bosco D, Casella C, Bogetti C, Bergamasco L, Fonio P, Gandini G. Comparison of synthetic mammography, reconstructed from digital breast tomosynthesis, and digital mammography: evaluation of lesion conspicuity and BI-RADS assessment categories. Breast Cancer Res Treat. 2017 Dec;166(3):765-773. doi: 10.1007/s10549-017-4458-3. Epub 2017 A PMID 28819781
- Bernardi D, Belli P, Benelli E, Brancato B, Bucchi L, Calabrese M, Carbonaro LA, Caumo F, Cavallo-Marincola B, Clauser P, Fedato C, Frigerio A, Galli V, Giordano L, Giorgi Rossi P, Golinelli P, Morrone D, Mariscotti G, Martincich L, Montemezzi S, Naldoni C, Paduos A, Panizza P, Pediconi F, Querci F, Rizzo A, Saguatti G, Tagliafico A, Trimboli RM, Zappa M, Zuiani C, Sardanelli F. Digital breast tom PMID 28540564
- Marinovich ML, Hunter KE, Macaskill P, Houssami N. Breast Cancer Screening Using Tomosynthesis or Mammography: A Meta-analysis of Cancer Detection and Recall. J Natl Cancer Inst. 2018 Sep 1;110(9):942-949. doi: 10.1093/jnci/djy121. PMID 30107542
Identifiers
NCT: NCT06854887 · DBT &Mammography in BIRADS 4-5