Clinical trial · Observational

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

NCT06854887CI-TRIAL-00086700not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Digital Breast Tomosynthesis	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
digital breast tomosynthesis and mammography	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (5)

measure
Recording The breast density in both tomosynthesis and mammography for the main and satellite lesions
timeFrame
baseline
description
The breast density according to ACR BIRADS in both tomosynthesis and mammography for the main and satellite lesions
measure
Recording the type of lesion in both tomosynthesis and mammography for the main and satellite lesions
timeFrame
baseline
description
the type of lesion (mass , microcalcification , architectural distortion) in both tomosynthesis and mammography for the main and satellite lesions
measure
Recording the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions
timeFrame
baseline
description
the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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

References

Publications (3)

RESULTMariscotti 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. PMID 28819781
RESULTBernardi 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. PMID 28540564
RESULTMarinovich 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