Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial.
INTRODUCTION
Development of digital breast tomosynthesis (DBT) provides a technology that generates three-dimensional data sets, thus reducing the pitfalls of overlapping breast tissue. Observational studies suggest that the combination of two-dimensional (2D) digital mammography and DBT increases diagnostic accuracy. However, because of duplicate exposure, this comes at the cost of an augmented radiation dose. This undesired adverse impact can be avoided by using synthesised 2D images reconstructed from the DBT data (s2D).We designed a diagnostic superiority trial on a high level of evidence with the aim of providing a comparison of screening efficacy parameters resulting from DBT+s2D versus the current screening standard 2D full-field digital mammography (FFDM) in a multicentre and multivendor setting on the basis of the quality-controlled, population-based, biennial mammography screening programme in Germany.


METHODS AND ANALYSIS
80 000 women in the eligible age 50-69 years attending the routine mammography screening programme and willing to participate in the TOSYMA trial will be assigned by 1:1 randomisation to either the intervention arm (DBT+s2D) or the control arm (FFDM) during a 12-month recruitment period in screening units of North Rhine-Westphalia and Lower Saxony. State cancer registries will provide the follow-up of interval cancers.Primary endpoints are the detection rate of invasive breast cancers at screening examination and the cumulative incidence of interval cancers in the 2 years after a negative examination. Secondary endpoints are the detection rate of ductal carcinoma in situ and of tumour size T1, the recall rate for assessment, the positive predictive value of recall and the cumulative 12-month incidence of interval cancers. An adaptive statistical design with one interim analysis provides the option to modify the design.


ETHICS AND DISSEMINATION
This protocol has been approved by the local medical ethical committee (2016-132-f-S). Results will be submitted to international peer-reviewed journals.


TRIAL REGISTRATION
NCT03377036; Pre-results.
['Weigel|Stefanie|S|0000-0002-8009-8831', 'Gerss|Joachim|J|', 'Hense|Hans-Werner|HW|', 'Krischke|Miriam|M|', 'Sommer|Alexander|A|', 'Czwoydzinski|Jörg|J|', 'Lenzen|Horst|H|', 'Kerschke|Laura|L|', 'Spieker|Karin|K|', 'Dickmaenken|Stefanie|S|', 'Baier|Sonja|S|', 'Urban|Marc|M|', 'Hecht|Gerold|G|', 'Heidinger|Oliver|O|', 'Kieschke|Joachim|J|', 'Heindel|Walter|W|']
D000368:Aged D001943:Breast Neoplasms D002285:Carcinoma, Intraductal, Noninfiltrating D005260:Female D005858:Germany D006801:Humans D008327:Mammography D008403:Mass Screening D008875:Middle Aged D011237:Predictive Value of Tests D016032:Randomized Controlled Trials as Topic D012042:Registries
digital breast tomosynthesis full-field digital mammography population-based screening breast imaging multicenter randomized controlled trial synthetic mammography