ToSyMa Study

What we have achieved:
Thanks to examinations using digital breast tomosynthesis (DBT), a further development of digital mammography technology, significantly more early breast cancer diagnoses are made in the quality-assured mammography screening program.

What we will be doing now:
We are currently investigating whether the higher breast cancer detection rate compared to digital mammography also leads to a higher level of women's health.

We say thank you:
Almost 100,000 women took part in the study and thus contributed to its success. We would like to thank them and the German Research Foundation (DFG), which provided significant funding for the study, as well as the participating screening units and study centers.
 

What we have achieved:

Breast cancer is the most common tumor disease for women in Germany.

For this reason, all women in Germany have been offered a quality-assured cancer screening examination from the age of 50 to 69 since 2009, and from 2024 to 75. They will be invited to have an X-ray examination of the breast, known as a screening mammogram. The aim is the early detection of breast cancer.
The latest scientific results from the University of Münster show that this systematic screening examination reduces breast cancer deaths by 20 to 30 percent. [ZEBra-MSP]

Digital breast tomosynthesis (DBT) is a further development of digital mammography. It generates a pseudo-3-dimensional image data set of the breast tissue in the form of slice images by swiveling the X-ray tube (see animation).

The advantage: uncertainties due to possible tissue overlaps are reduced. With computer support, a 2-dimensional image can be calculated from the tomosynthesis data set: the so-called synthetic mammogram.

Our ToSyMa study, which was conducted between 2018 and 2020, examined the early detection rates of the innovative combination of DBT with synthetic 2D mammography in comparison with conventional screening mammography. The result: significantly more early diagnoses can be made with DBT. [ToSyMa-1]
 

What we will be doing now:

Whether the higher breast cancer detection rate in DBT screening also leads to a higher level of women's health is currently being investigated. The state cancer registries of North Rhine-Westphalia and Lower Saxony are providing data from the follow-up. [ToSyMa-2]
 

We say thank you:

Almost 100,000 women have taken part in the ToSyMa study and thus contributed to its success.

Our sincere thanks go to them and to the German Research Foundation (DFG), which has provided significant funding for the study since 2016 until 2026.

We would also like to thank all the study teams in the 17 participating screening units.

Publications

Radiological Tumor Signs of Breast Cancer in UICC Stage I: Subanalysis of the Randomized Controlled Trial TOSYMA
S. Weigel, H.W. Hense, V. Weyer-Elberich, J. Gerß, W. Heindel
Rofo. 2025 Mar 26. doi: 10.1055/a-2544-9085. Online ahead of print.

Radiation exposure and screening yield by digital breast tomosynthesis compared to mammography: results of the TOSYMA Trial breast density related
A. Sommer, S. Weigel, H.W. Hense, J. Gerß, V. Weyer-Elberich, L. Kerschke, E. Nekolla, H. Lenzen, W. Heindel
Eur Radiol. 2025 Jan;35(1):166-176. doi: 10.1007/s00330-024-10847-9. Epub 2024 Jul 16.

Increased detection of relevant breast cancers with DBT in mammography screening?
S. Weigel, V. Weyer-Elberich, H.W. Hense, T. Decker, J. Gerß, W. Heindel
Senologie - Zeitschrift für Mammadiagnostik und -therapie 2024; 21(03): 219-226. doi: 10.1055/a-2287-2854

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 Aug;196(8):834-842. doi: 10.1055/a-2216-1109. Epub 2024 Jan 31.

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.

Intratumoral heterogeneity after targeted therapy in murine cancer models with differing degrees of malignancy
M. Gerwing, E. Hoffmann, C. Geyer, A. Helfen, B. Maus, R. Schinner, L. Wachsmuth, W. Heindel, M. Eisenblaetter, C. Faber, M. Wildgruber
Transl Oncol. 2023 Nov:37:101773. doi: 10.1016/j.tranon.2023.101773. Epub 2023 Sep 2.

Artificial Intelligence for Indication of Invasive Assessment of Calcifications in Mammography Screening
S. Weigel, A. Brehl, W. Heindel, L. Kerschke
Rofo. 2023 Jan;195(1):38-46. doi: 10.1055/a-1967-1443. Epub 2023 Jan 1.

Multiparametric MRI enables for differentiation of different degrees of malignancy in two murine models of breast Cancer
M. Gerwing, E. Hoffmann, K. Kronenberg, U. Hansen, M. Masthoff, A. Helfen, C. Geyer, L. Wachsmuth, C. Höltke, B. Maus, V. Hoerr, T. Krähling, L. Hiddeßen, W. Heindel, U. Karst, M. A. Kimm, R. Schinner, M. Eisenblätter, C. Faber, M. Wildgruber
Front Oncol. 2022 Nov 2:12:1000036. doi: 10.3389/fonc.2022.1000036. eCollection 2022.

Initial Results of 68Ga-FAPI-46 PET/MRI to Assess Response to Neoadjuvant Chemotherapy in Breast Cancer
P. Backhaus, M. C. Burg, I. Asmus, M. Pixberg, F. Büther, H.-J. Breyholz, R. Yeh, S. Weigel, P. Stichling, W. Heindel, S. Bobe, P. Barth, J. Tio, M. Schäfers
J Nucl Med. 2023 May;64(5):717-723. doi: 10.2967/jnumed.122.264871. Epub 2022 Nov 17.

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

Surrogate endpoints in breast cancer screening trials - Authors' Reply
W. Heindel, S. Weigel, H.W. Hense
Lancet Oncol. 2022 Aug;23(8):e361. doi: 10.1016/S1470-2045(22)00396-5.

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.

Simultaneous FAPI PET/MRI Targeting the Fibroblast-Activation Protein for Breast Cancer
P. Backhaus, M. C. Burg, W. Roll, F. Büther, H.J. Breyholz, S. Weigel, W. Heindel, M. Pixberg, P. Barth, J. Tio, M. Schäfers
Radiology. 2022 Jan;302(1):39-47. doi: 10.1148/radiol.2021204677. Epub 2021 Oct 12.

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.

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
BMJ Open. 2020 Nov 2022

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.

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