Tomosynthesis Versus Digital Mammography in a Population-based Screening Program
im3D S.p.A.
SCDO Epidemiologia dei Tumori, AOU Città della Salute e della Scienza di Torino

      Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis
      (DBT) is more sensitive and more specific than conventional digital mammography (DM).
      However, large randomised controlled trials (RCTs) are needed to confirm these promising
      results. Furthermore, potential side effects of DBT in the screening setting have to be
      properly evaluated. In particular, the major concern is about overdiagnosis and its
      consequences; overdiagnosis refers to the detection of cancers at screening, which would not
      have become clinically apparent in the woman's lifetime.

      This RCT was designed to compare benefits and harms of DBT in a population-based screening
      program with conventional DM. The primary outcome parameter will be the difference between
      the two tests in rates of advanced cancers detected at the subsequent round and interval
      cancers (within the first two years after the study screening round). Secondary outcomes
      measures will be diagnostic performance indicators for organised breast screening (i.e,
      cancer detection rate, recall rate, false positive rate, positive predictive value),
      parameters used in cost-effectiveness analysis, pathologic and biological characteristics of
      screen-detected cancers.
    
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