Clinical trial · Interventional
Tomosynthesis as Primary Test for Breast Cancer Screening
Tomosynthesis as Primary Test for Breast Cancer Screening: A Multicenter Randomized Controlled Trial
NCT04461808CI-TRIAL-00119299MAITAactive 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)
Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| digital mammography | Diagnostic Test | — | UNRESOLVED |
| tomosynthesis + synthetic 2D | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tomosynthesis + synthetic 2D
- description
- Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.
- interventionNames
- Diagnostic Test: tomosynthesis + synthetic 2D
- type
- ACTIVE_COMPARATOR
- label
- Digital Mammography
- description
- Women will be screened for digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.
- interventionNames
- Diagnostic Test: digital mammography
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Women scheduled for a new round of mammographic screening * resident in the province 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 (0)
Data not yet available
No reference posted for this study.