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Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial
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  • Published on:
    The TOSYMA RCT: Increasing the study sample size to assess the effect of DBT on interval cancer rates in mammography screening
    • Walter Heindel, Professor of Radiology and Chairman Clinic for Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Münste

    Walter Heindel 1, Stefanie Weigel 1, Laura Kerschke 2, Karin Spieker 3, Hans-Werner Hense 4, Joachim Gerss 2

    1 Clinic for Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Münster, Germany.
    2 Institute of Biostatistics and Clinical Research, IBKF, University of Münster, Münster, Germany.
    3 Center for Clinical Trials Münster, University Hospital Münster, Münster, Germany.
    4 Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany.

    Correspondence to Prof. Walter Heindel; heindel@uni-muenster.de

    The first primary objective of the TOSYMA trial (ClinicalTrials.gov Identifier NCT03377036; https://clinicaltrials.gov/ct2/show/NCT03377036) is to investigate the hypothesis that digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) leads to a clinically relevant increase in the detection rate of screen-detected invasive cancers compared with standard 2D full-field digital mammography (2D-FFDM) (1).
    The expected increase in cancer detection by the novel technique, however, needs to be balanced against the potential for overdiagnosis. The 24-months cumulative incidence of invasive interval cancers in screen-negative women is therefore defined as a second primary endpoint in the study protocol (1): higher invasive cancer detection r...

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    Conflict of Interest:
    None declared.