These results confirm the assumption that by using the new enhanced mammography technology, breast cancer is detected significantly more often than by using standard mammography. This observation is due to the fact that the innovative imaging method reduces the probability of masking radiological signs of malignancy by overlapping tissue structures.
The 17 study centers involved in the states of North Rhine-Westphalia and Lower Saxony were able to persuade almost 100,000 women to take part in the diagnostic comparative study. Study phase 2 will examine whether the increase in breast cancer diagnoses as a result of screening also leads to improved health in women. To this end, cancer register data will be evaluated up to two years after participation in the study.
The German Research Foundation (DFG) is providing funding for the follow-up-study – over 1.6 million euros up to 2025. In doing so, the DFG is supporting the aim of further improving the early detection of breast cancer. Breast tomosynthesis – an enhanced version of digital mammography – provides technology which, by computing pseudo-3D datasets, reduces any potential overlapping of tissue in the breast, thus promising benefits in making diagnoses.
The ToSyMa study was led by Prof. Walter Heindel, Director of the Radiology Department at Münster University Hospital (UKM), as principle investigator and the project manager Prof. Stefanie Weigel. Both expressed their gratitude to the 100,000 women who took part in the study: "It is only their participation that enables meaningful research to be carried out, and our thanks go also to the German Research Foundation with their funding for this large-scale, randomized diagnostic superiority study," they said.
For the purpose of data collection for the study, women who had agreed to take part in the screening were allocated at random (with a probability of 1:1) either to the group using standard screening mammography or to the group using tomosynthesis combined with synthetic 2D mammography. In both groups, the detection rates for breast cancer were compared. The allocation was undertaken using a computer program and could not be influenced by anyone (randomized controlled clinical study). Between 2018 and the end of 2020, women in North Rhine-Westphalia and Lower Saxony who received their regular written invitation to a screening also received an invitation (at random) to take part in the study.
MEDICA-tradefair.com; Source: University of Münster
