Do improvements in the digital technologies used for the early detection of breast cancer also result in increased efficiency in mammography screening? This is the question at the heart of a large-scale research project being undertaken by the Institute of Clinical Radiology at Münster University Hospital (UKM). The so-called ToSyMa study will examine whether technical developments in digital mammography towards image sectioning methods (digital breast tomosynthesis) represent a positive advance over the current standard of two-dimensional mammography screenings. The aim is to recruit 80,000 eligible women between the ages of 50 and 69, who have opted to take part in a screening, to allow their data to be collected for the study. The diagnostic study, which has been developed by an interdisciplinary team at the University of Münster, is of a high scientific standard and is being funded by the German Research Foundation (DFG).
The women will be assigned at random, and on a 50:50 basis, either to the group having a standard mammography or to the group having tomosynthesis with a resulting synthetic mammography. In both groups, the detection rates for breast cancer and the frequency of further assessment will be compared. Assignation to either of the two groups is carried out using a computer programme and cannot be influenced by anyone – providing the basis for a randomised, clinical study.
The examinations are to be carried out over a twelve-month period at 17 screening units in the federal states of North Rhine-Westphalia and Lower Saxony. ToSyMa will be starting this month, after several years of conceptual groundwork preparing it. From June onwards, women will be receiving their regular written invitation to a screening, along with an invitation to some of them, selected at random, to take part in the study. More than 200,000 invitations will be sent out.
“The further development of digital mammography towards breast tomosynthesis provides technology which, by creating three-dimensional data sets, reduces potential tissue overlays in the breast and can therefore offer diagnostic advantages. The first results from the ToSyMa study are expected in late 2020, with the final results being available in 2023,” says Prof. Walter Heindel, Director of the Institute of Clinical Radiology (IKR) at Münster University Hospital. The project name is an abbreviation, derived from the English title of the study: “Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening”).
In Germany more than 70,000 women are diagnosed every year as having breast cancer, and 17,500 die of it. It was for this reason that a nationwide, quality-assured mammography screening project was introduced in Germany with the aim of reducing the number of women dying of breast cancer.
Every two years, all women between the ages of 50 and 69 are invited to attend an X-ray examination. The health insurance funds bear the costs of the early detection programme as one of their standard benefits offered to everyone. Since the programme was begun there has been a decrease in incidences of breast cancer detected at an advanced stage after a second screening.
Stefanie Weigel, Joachim Gerss, Hans-Werner Hense, Miriam Krischke, Alexander Sommer, Jörg Czwoydzinski, Horst Lenzen, Laura Kerschke, Karin Spieker, Stefanie Dickmaenken, Sonja Baier, Marc Urban, Gerold Hecht, Oliver Heidinger, Joachim Kieschke, Walter Heindel.
Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial.
BMJ Open. 2018 May 14;8(5):e020475. doi: 10.1136/bmjopen-2017-020475.