Clinical trial · Interventional
Screening for Breast Cancer With Digital Breast Tomosynthesis
Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group
NCT02698202CI-TRIAL-00099377completedN/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)
Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Breast Tomosynthesis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Digital Breast Tomosynthesis
- description
- to the experimental arm will be offered twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis
- interventionNames
- Device: Digital Breast Tomosynthesis
- type
- NO_INTERVENTION
- label
- standard mammography
- description
- to the control arm the usual 2D standard mammography exam will be offered
Primary outcomes (2)
- measure
- cumulative incidence of T2+ cancers after screening
- timeFrame
- 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 45-70 years old women invited to breast cancer screening program who accepted to participate Exclusion Criteria: * previous breast cancer diagnosis * pregnancy or suspicion of pregnancy * presence of BRCA1/2 gene mutation * Previous Digital Breast Tomosynthesis performed * unable to understand informed consent * chemotherapy in progress * presence of breast implant
References
Publications (1)
- DERIVEDPattacini P, Nitrosi A, Giorgi Rossi P, Duffy SW, Iotti V, Ginocchi V, Ravaioli S, Vacondio R, Mancuso P, Ragazzi M, Campari C; RETomo Working Group. A Randomized Trial Comparing Breast Cancer Incidence and Interval Cancers after Tomosynthesis Plus Mammography versus Mammography Alone. Radiology. 2022 May;303(2):256-266. doi: 10.1148/radiol.211132. Epub 2022 Feb 1. PMID 35103537