Almost 100,000 participants: “ToSyMa” study on breast cancer screening is extended
The German Research Foundation is funding the continuation and expansion of the „ToSyMa“ study at the University of Münster: one of the world’s largest investigations of digital imaging techniques for the early detection of breast cancer and their impact on efficiency in mammography screening.
At the University of Münster, research is being undertaken into the further development of digital imaging techniques for the early detection of breast cancer and what impact they have on the efficiency of mammography screening. The activities being undertaken in this area include “ToSyMa”, the largest study of its kind worldwide. From 2018 until the end of 2020 – in other words, despite the corona restrictions – it was possible to enlist the aid of exactly 99,689 women to participate in this diagnostic field study, which took place in 17 study centres in the German states of North Rhine-Westphalia and Lower Saxony. The database will be closed on 30 June – but ToSyMa will continue. The German Research Foundation (DFG) is to provide funding of more than 1.6 million euros until 2025 for a continuation and expansion of the study, for which originally only 80,000 participants were planned.
In doing so, the DFG is supporting the objective of assessing the chances of making improvements in the detection of breast cancer. The ToSyMa study – undertaken by an interdisciplinary team at the University of Münster – is investigating whether further technical developments in digital mammography towards image sectioning methods (digital breast tomosynthesis) improves the current standard of screening, which itself consists of a two-dimensional mammography examination.
In the words of Prof. Walter Heindel, who is leading the study, the large number of women taking part is evidence of the high level of acceptance of the systematic early detection of breast cancer in the German screening programme. Heindl, who is Director of the Radiological Clinic and Head of the Mammography Reference Centre at Münster University Hospital, reports that there are high expectations of the study worldwide. The further development of digital mammography towards breast tomosynthesis provides technology which, says Heindl, “by creating three-dimensional data sets, reduces potential tissue overlays in the breast and can therefore offer diagnostic advantages.” In a first step, the research group aims to assess the level of knowledge relating to increased breast cancer detection in the screening programme. What this means in practical terms is: What more can be achieved to help women that 2D mammography screening was not previously capable of? Secondly, the quota of mammary carcinoma detected in women in a period of two years after they have participated in a screening session will be compared with the tomosynthesis test group and the control group.
For the purpose of data acquisition in the study, women who opted to take part in the screening were allocated at random, and on a 50:50 basis, either to the group having standard mammography or to the group undergoing tomosynthesis with a resulting synthetic mammography. In both groups, the detection rates for breast cancer and the frequency of further diagnoses will be compared. Allocation to either of the two groups is carried out using a computer programme and cannot be influenced by anyone. Experts call this a randomised, clinical study.
From 2018 onwards, women in North Rhine-Westphalia and Lower Saxony received their regular written invitation to a screening, together with an invitation, selected at random, to take part in the study. The first interim results for ToSyMa are expected at the end of 2021.
Prof. Walter Heindel
Director of the Radiological Clinic
and Head of the Mammography Reference Centre at Münster University Hospital
Münster University Hospital
Albert-Schweitzer-Campus 1 (Gebäude A1), 48149 Münster
Telephone +49 (0)251 83-45650
Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population based screening (TOSYMA): protocol of a randomized controlled trial.
Weigel S, Gerss J, Hense HW, Krischke M, Sommer A, Czwoydzinski J, Lenzen H, Kerschke L, Spieker K, Dickmaenken S, Baier S, Urban M, Hecht G, Heidinger O, Kieschke J, Heindel W.
BMJ Open 2018; 0:e020475. doi:10.1136/bmjopen-2017-02
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The TOSYMA RCT: Increasing the study sample size to assess the effect of DBT on interval canceer rates in mammography screening.
Heindel W, Weigel S, Kerschke L, Spieker K Hense H-W, Gerss K.
Published on 25 November 2020