Clinical trial · Interventional
Innovation in Mammography: Tomosynthesis Pathways
NCT03587259CI-TRIAL-00033773IMPETOunknownN/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)
The study aims at evaluating the introduction of tomosynthesis in mammography screening, analyzing the benefits, disadvantages and feasibility in current clinical practice. It involves women aged 45-46 that will be divided, by drawing lots, into two groups: one group will do the 2D digital mammography (control group), while the other group (intervention group) will do tomosynthesis. In the intervention group the 2D two-dimensional mammography will be reconstructed starting from tomosynthesis without exposing women to other radiation.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2D mammography | Diagnostic Test | — | UNRESOLVED |
| Tomosynthesis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 2D mammography
- description
- 45-46 years old women are invited to attend the usual screening examination (2D mammography). The next year they will be invited to make a 2D mammography, according to screening protocol.
- interventionNames
- Diagnostic Test: 2D mammography
- type
- EXPERIMENTAL
- label
- Tomosynthesis
- description
- 45-46 years old women are invited to attend the Digital Breast Tomosynthesis (DBT) in adjunct to synthetic mammograms (sDM). The next year they will be invited to make a 2D mammography, according to screening protocol.
- interventionNames
- Diagnostic Test: Tomosynthesis
Primary outcomes (1)
- measure
- the cumulative incidence of advanced screen-detected cancers (T2 +) and the cumulative incidence of advanced interval cancers (T2 +)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 46 Years
Show eligibility criteria text
Inclusion Criteria: * 45-46 years old women resident in the screening area Exclusion Criteria: * previous breast cancer * written refusal to participate in the screening programme * pregnancy, breastfeeding * presence of prostheses; * ongoing chemotherapy; * impossibility to submit the informed consent for linguistic problems or for inability of women to provide informed consent; * verified presence of BRCA1 - BRCA2 (Breast Related Cancer Antigens 1 - Breast Related Cancer Antigens 2) genetic mutation or involvement in surveillance path for heredo-familial tumor; * previous known tomosynthesis.
References
Publications (10)
- BACKGROUNDCiatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, Tuttobene P, Bricolo P, Fanto C, Valentini M, Montemezzi S, Macaskill P. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol. 2013 Jun;14(7):583-9. doi: 10.1016/S1470-2045(13)70134-7. Epub 2013 Apr 25. PMID 23623721
- BACKGROUNDSkaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013 Apr;267(1):47-56. doi: 10.1148/radiol.12121373. Epub 2013 Jan 7. PMID 23297332
- BACKGROUNDGilbert FJ, Tucker L, Gillan MG, Willsher P, Cooke J, Duncan KA, Michell MJ, Dobson HM, Lim YY, Purushothaman H, Strudley C, Astley SM, Morrish O, Young KC, Duffy SW. The TOMMY trial: a comparison of TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme--a multicentre retrospective reading study comparing the diagnostic performance of digital breast tomosynthesis and digital mammography with digital mammography alone. Health Technol Assess. 2015 Jan;19(4):i-xxv, 1-136. doi: 10.3310/hta19040. PMID 25599513
- BACKGROUNDSkaane P, Bandos AI, Eben EB, Jebsen IN, Krager M, Haakenaasen U, Ekseth U, Izadi M, Hofvind S, Gullien R. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Radiology. 2014 Jun;271(3):655-63. doi: 10.1148/radiol.13131391. Epub 2014 Jan 24. PMID 24484063
- BACKGROUNDPaci E, Mantellini P, Giorgi Rossi P, Falini P, Puliti D; TBST Working Group. [Tailored Breast Screening Trial (TBST)]. Epidemiol Prev. 2013 Jul-Oct;37(4-5):317-27. Italian. PMID 24293498
- BACKGROUNDMcDonald ES, McCarthy AM, Akhtar AL, Synnestvedt MB, Schnall M, Conant EF. Baseline Screening Mammography: Performance of Full-Field Digital Mammography Versus Digital Breast Tomosynthesis. AJR Am J Roentgenol. 2015 Nov;205(5):1143-8. doi: 10.2214/AJR.15.14406.