Clinical trial · Interventional
Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography
Prospective Randomized Comparison of Digital Breast Tomosynthesis Plus Synthesized Images Versus Standard Full-field Digital Mammography in Population-based Screening (TOSYMA)
NCT03377036CI-TRIAL-00101555TOSYMAactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a randomized, multicenter, multivendor, controlled, diagnostic superiority trial to compare digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) versus standard 2D full-field digital mammography (2D-FFDM) regarding the effectiveness as screening modality.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Screening | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2D-FFDM | Diagnostic Test | — | UNRESOLVED |
| DBT+s2D | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DBT+s2D
- description
- Digital breast tomosynthesis plus synthesized 2D mammograms
- interventionNames
- Diagnostic Test: DBT+s2D
- type
- ACTIVE_COMPARATOR
- label
- 2D-FFDM
- description
- 2D full-field digital mammography
- interventionNames
- Diagnostic Test: 2D-FFDM
Primary outcomes (2)
- measure
- Detection rate of invasive breast cancers
- timeFrame
- Routine screening visit
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Women eligible to participate in the National Mammography Screening Program of Germany * Informed decision for mammography screening * Written informed consent * No prior participation in the TOSYMA trial Exclusion Criteria: * Breast cancer up to 5 years prior to study invitation * Previous mammography examination \< 12 months, * Breast implants
References
Publications (4)
- BACKGROUNDWeigel S, Gerss J, Hense HW, Krischke M, Sommer A, Czwoydzinski J, Lenzen H, Kerschke L, Spieker K, Dickmaenken S, Baier S, Urban M, Hecht G, Heidinger O, Kieschke J, Heindel W. 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. PMID 29764880
- DERIVEDWeigel S, Hense HW, Weyer-Elberich V, Gerss J, Heindel W; TOSYMA Screening Trial Group. False-Positive Recall and False-Positive Biopsy Rates in Mammography Screening: A TOSYMA Trial Subanalysis. Radiology. 2025 Sep;316(3):e251014. doi: 10.1148/radiol.251014. PMID 40956160
- DERIVEDWeigel S, Heindel W, Hense HW, Decker T, Gerss J, Kerschke L; TOSYMA Screening Trial Study Group. Breast Density and Breast Cancer Screening with Digital Breast Tomosynthesis: A TOSYMA Trial Subanalysis. Radiology. 2023 Feb;306(2):e221006. doi: 10.1148/radiol.221006. Epub 2022 Oct 4. PMID 36194110
- DERIVEDHeindel W, Weigel S, Gerss J, Hense HW, Sommer A, Krischke M, Kerschke L; TOSYMA Screening Trial Study Group. Digital breast tomosynthesis plus synthesised mammography versus digital screening mammography for the detection of invasive breast cancer (TOSYMA): a multicentre, open-label, randomised, controlled, superiority trial. Lancet Oncol. 2022 May;23(5):601-611. doi: 10.1016/S1470-2045(22)00194-2. Epub 2022 Apr 12. PMID 35427470