Clinical trial NCT06854887: The Added Value of DBT Over Mammography in Local Tumor Staging in Patients With BIRADS 4 or 5 Lesions
Official title: The Added Value of Digital Breast Tomosynthesis Over Mammography in Local Tumor Staging in Patients With BIRADS 4 or 5 Lesions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Digital Breast Tomosynthesis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recording The breast density in both tomosynthesis and mammography for the main and satellite lesions
timeFrame: baseline
measure: Recording the type of lesion in both tomosynthesis and mammography for the main and satellite lesions
timeFrame: baseline
measure: Recording the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions
timeFrame: baseline
measure: 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
timeFrame: baseline
measure: Recording the tumor histopathology type for the main and satellite lesions
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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 Aug 17.
citation: 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 tomosynthesis (DBT): recommendations from the Italian College of Breast Radiologists (ICBR) by the Italian Society of Medical Radiology (SIRM) and the Italian Group for Mammography Screening (GISMa). Radiol Med. 2017 Oct;122(10):723-730. doi: 10.1007/s11547-017-0769-z. Epub 2017 May 25.
citation: 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.