Evidence map›Paper›PMID 36194110›Full record

Trial reportRadiology2023

Breast Density and Breast Cancer Screening with Digital Breast Tomosynthesis: A TOSYMA Trial Subanalysis.

Stefanie Weigel, Walter Heindel, Hans-Werner Hense, Thomas Decker, Joachim Gerß, Laura Kerschke, TOSYMA Screening Trial Study Group

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Radiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03377036 (Prospective Randomized Comparison of Digital Breast Tomosynthesis Plus Synthesized Images Versus Standard Full-field Digital Mammography in Population-based Screening), which is not on this map. Cited by 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 pooled it
7.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03377036 naactive not recruitingnot on this map

Prospective Randomized Comparison of Digital Breast Tomosynthesis Plus Synthesized Images Versus Standard Full-field Digital Mammography in Population-based Screening (TOSYMA)

TypeinterventionalSponsorUniversity Hospital MuensterRan2018 to 2027Enrolled99,689ConditionsBreast Cancer ScreeningArmsDBT+s2D, 2D-FFDM
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Guideline
  2. Extending the Age Range in Mammography Screening: A Benefit-Risk Assessment from a Radiation Protection Perspective.RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin · 2026
    Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Breast MRI to Screen Women With Extremely Dense Breasts.Journal of magnetic resonance imaging : JMRI · 2025
    Review
  10. Review
  11. Observational
  12. Article
  13. Review
  14. [Structured screening for sporadic breast cancer].Radiologie (Heidelberg, Germany) · 2024
    Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Stefanie Weigel *From the Clinic for Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Albert-Schweitzer-Campus 1, Building A1, D-48149 Münster, Germany (S.W., W.H., T.D.); Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany (H.W.H.); and Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany (J.G., L.K.).ORCID 0000-0002-8009-8831
Walter Heindel *From the Clinic for Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Albert-Schweitzer-Campus 1, Building A1, D-48149 Münster, Germany (S.W., W.H., T.D.); Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany (H.W.H.); and Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany (J.G., L.K.).ORCID 0000-0002-6562-280X
Hans-Werner HenseFrom the Clinic for Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Albert-Schweitzer-Campus 1, Building A1, D-48149 Münster, Germany (S.W., W.H., T.D.); Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany (H.W.H.); and Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany (J.G., L.K.).ORCID 0000-0002-7381-1547
Thomas DeckerFrom the Clinic for Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Albert-Schweitzer-Campus 1, Building A1, D-48149 Münster, Germany (S.W., W.H., T.D.); Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany (H.W.H.); and Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany (J.G., L.K.).ORCID 0000-0001-9162-9100
Joachim Gerß *From the Clinic for Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Albert-Schweitzer-Campus 1, Building A1, D-48149 Münster, Germany (S.W., W.H., T.D.); Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany (H.W.H.); and Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany (J.G., L.K.).ORCID 0000-0003-3489-683X
Laura Kerschke *From the Clinic for Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Albert-Schweitzer-Campus 1, Building A1, D-48149 Münster, Germany (S.W., W.H., T.D.); Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany (H.W.H.); and Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany (J.G., L.K.).ORCID 0000-0002-1195-7399
TOSYMA Screening Trial Study GroupFrom the Clinic for Radiology and Reference Center for Mammography Münster, University of Münster and University Hospital Münster, Albert-Schweitzer-Campus 1, Building A1, D-48149 Münster, Germany (S.W., W.H., T.D.); Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany (H.W.H.); and Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany (J.G., L.K.).
University of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Digital breast tomosynthesis (DBT) plus synthesized mammography (SM) reduces the diagnostic pitfalls of tissue superimposition, which is a limitation of digital mammography (DM). Purpose To compare the invasive breast cancer detection rate (iCDR) of DBT plus SM versus DM screening for different breast density categories. Materials and Methods An exploratory subanalysis of the TOmosynthesis plus SYnthesized MAmmography (TOSYMA) study, a randomized, controlled, multicenter, parallel-group trial recruited within the German mammography screening program from July 2018 to December 2020. Women aged 50-69 years were randomly assigned (1:1) to DBT plus SM or DM screening examination. Breast density categories A-D were visually assessed according to the Breast Imaging Reporting and Data System Atlas. Exploratory analyses were performed of the iCDR in both study arms and stratified by breast density, and odds ratios and 95% CIs were determined. Results A total of 49 762 women allocated to DBT plus SM and 49 796 allocated to DM (median age, 57 years [IQR, 53-62 years]) were included. In the DM arm, the iCDR was 3.6 per 1000 screening examinations in category A (almost entirely fatty) (16 of 4475 screenings), 4.3 in category B (102 of 23 534 screenings), 6.1 in category C (116 of 19 051 screenings), and 2.3 in category D (extremely dense breasts) (six of 2629 screenings). The iCDR in the DBT plus SM arm was 2.7 per 1000 screening examinations in category A (12 of 4439 screenings), 6.9 in category B (154 of 22 328 screenings), 8.3 in category C (156 of 18 772 screenings), and 8.1 in category D (32 of 3940 screenings). The odds ratio for DM versus DBT plus SM in category D was 3.8 (95% CI: 1.5, 11.1). The invasive cancers detected with DBT plus SM were most often grade 2 tumors; in category C, it was 58% (91 of 156 invasive cancers), and in category D, it was 47% (15 of 32 invasive cancers). Conclusion The TOmosynthesis plus SYnthesized MAmmography trial revealed higher invasive cancer detection rates with digital breast tomosynthesis plus synthesized mammography than digital mammography in dense breasts, relatively and absolutely most marked among women with extremely dense breasts. ClinicalTrials.gov registration no.: NCT03377036 © RSNA, 2022

Indexed as

Breast NeoplasmsBreastBreast DensityEarly Detection of CancerFemaleHumansMammographyMass ScreeningMiddle Aged

Identifiers

PMID36194110
OpenAlexW4301391924

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.