What we have achieved:
Our randomized controlled trial (RCT) using the combination of digital breast tomosynthesis (DBT) – an enhanced version of digital mammography technology – and synthesised 2D mammograms showed considerably more early diagnoses of breast cancer than quality-assured digital 2D mammography – the worldwide screening standard so far.

What we will be doing now:
The running follow-up study in the coming two years examines whether the higher detection rate of invasive breast cancer also leads to an improved level of women’s health.

We say thank you:
Almost 100,000 women took part in the study, thus contributing to its success. We are very grateful indeed to them – as well as to the German Research Foundation (DFG), which provided significant funding for the study, and to the 17 Screening Centres involved.
 

Breast cancer is meanwhile the most frequent tumour disease worldwide.

Therefore, in Germany since 2009, all women between the ages of 50 and 69 have been offered a digital mammography – an X-ray examination of the breast – as part of a national cancer screening programme. The aim is the early detection of breast cancer in order to reduce the number of deaths relating to the disease.

Digital breast tomosynthesis (DBT) is an enhanced version of digital mammography. The X-ray tube rotates over the breast, producing a pseudo-3-dimensional image dataset of the breast tissue in the form of a tomogram (a stack of images). See animation below.

The advantage of this is that uncertainties resulting from overlapping tissue are reduced. With the aid of a computer, a 2-dimensional image – the synthetic mammography – can be produced from the tomosynthesis dataset.

The first phase of our ToSyMa Study examined the detection rates of invasiv breast cancer from the innovative combination of DBT with synthetic 2D-mammography compared to the current standard. The result was that significantly more early diagnoses can be made with DBT.  [ToSyMa-1]
 

Studies will be carried out in the coming two years to see whether the higher detection rate for breast cancer using DBT screening – compared with digital mammography – also leads to an improved level of women’s health. The cancer registers in the federal states of North Rhine-Westphalia and Lower Saxony will be supplying the data for follow-up observation. [ToSyMa-2]

Almost 100,000 women took part in the ToSyMa Study, thus contributing to its success.

We are very grateful indeed to them – as well as to the German Research Foundation (DFG), which has been providing significant funding for the study, and will continue to do so until 2025

Equally, we would like to thank all the study teams in the 17 Screening Centres involved

Breast cancer screening with digital breast tomosynthesis: Is independent double reading still required?
S. Weigel, H.W. Hense, V. Weyer-Elberich, J. Gerß, W. Heindel
Rofo. 2024 Jan 31. doi: 10.1055/a-2216-1109

Digital Breast Tomosynthesis versus Digital Mammography for Detection of Early-Stage Cancers Stratified by Grade: A TOSYMA Subanalysis
S. Weigel* , W. Heindel*, T. Decker, V. Weyer-Elberich, L. Kerschke, J. Gerß, H.W. Hense, for the TOSYMA Screening Trial Study Group
*S.W. and W.H. contributed equally to this work.
Radiology. 2023 Dec;309(3):e231533. doi: 10.1148/radiol.231533.

Breast Cancer Detection: Digital Breast Tomosynthesis with Synthesized Mammography versus Digital Mammography
Su Min Ha, Jung Min Chang
Radiology. 2023 Dec;309(3):e232911. doi: 10.1148/radiol.232911.

Breast Density and Breast Cancer Screening with Digital Breast Tomosynthesis: A TOSYMA Trial Subanalysis
S. Weigel*, W. Heindel*, H.W. Hense, T. Decker, J. Gerß, L. Kerschke, for the TOSYMA Screening Trial Study Group
*SW and WH contributed equally to this work.
Radiology. 2023 Feb;306(2):e221006. doi: 10.1148/radiol.221006. Epub 2022 Oct 4.

Lessons Learned from the Randomized Controlled TOmosynthesis plus SYnthesized MAmmography (TOSYMA) Trial
Cindy S. Lee, Linda Moy
Radiology. 2023 Feb;306(2):e222178. doi: 10.1148/radiol.222178. Epub 2022 Oct 4.

Erste Ergebnisse zur multizentrischen, randomisierten, kontrollierten Brustkrebs-Diagnostikstudie ToSyMa
W. Heindel, S. Weigel
Senologie - Zeitschrift für Mammadiagnostik und -therapie 2022; 18(02): 125-126; DOI: 10.1055/a-1826-6228

Digital breast tomosynthesis plus synthesized mammography versus digital screening mammography for the detection of invasive breast cancer (TOSYMA): a multicentre, open-label, randomized, controlled, superiority trial
W. Heindel*, S. Weigel*, J. Gerß, H.W. Hense, A. Sommer, M. Krischke, L. Kerschke, for the TOSYMA Screening Trial Study Group
*WH and SW contributed equally to this work.
Lancet Oncol. 2022 May;23(5):601-611. doi: 10.1016/S1470-2045(22)00194-2. Epub 2022 Apr 12.

Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial
S. Weigel, J. Gerss, H.W. Hense, M. Krischke, A. Sommer, J. Czwoydzinski, H. Lenzen, L. Kerschke, K. Spieker, S. Dickmaenken, S. Baier, M. Urban, G. Hecht, O. Heidinger, J. Kieschke, W. Heindel
BMJ Open. 2018 May 14;8(5):e020475. doi: 10.1136/bmjopen-2017-020475.

The TOSYMA RCT: Increasing the study sample size to assess the effect of DBT on interval cancer rates in mammography screening
W. Heindel, S. Weigel, L. Kerschke, K. Spieker, H.W. Hense, J. Gerss

Systematische und qualitätsgesicherte Früherkennung des sporadischen Mammakarzinoms: Update Screening-Effekte und wissenschaftliche Studien
W. Heindel, K. Bock, G. Hecht, S. Heywang-Köbrunner, V. Kääb-Sanyal, K. Siegmann-Luz, S. Weigel
Radiologe. 2021 Feb;61(2):126-136. doi: 10.1007/s00117-020-00803-1. Epub 2021 Jan 25.

Study registration on ClinicalTrial.gov

DFG project page on the ToSyMa study

Medical Tribune articel "3D-Blick auf die Brust"