Clinical trial · Interventional
Tomosynthesis Versus Digital Mammography in a Population-based Screening Program
Digital Breast Tomosynthesis Versus Digital Mammography in a Population-based Screening Program. A Controlled Randomized Multicenter Trial
- 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)
Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis (DBT) is more sensitive and more specific than conventional digital mammography (DM). However, large randomised controlled trials (RCTs) are needed to confirm these promising results. Furthermore, potential side effects of DBT in the screening setting have to be properly evaluated. In particular, the major concern is about overdiagnosis and its consequences; overdiagnosis refers to the detection of cancers at screening, which would not have become clinically apparent in the woman's lifetime. This RCT was designed to compare benefits and harms of DBT in a population-based screening program with conventional DM. The primary outcome parameter will be the difference between the two tests in rates of advanced cancers detected at the subsequent round and interval cancers (within the first two years after the study screening round). Secondary outcomes measures will be diagnostic performance indicators for organised breast screening (i.e, cancer detection rate, recall rate, false positive rate, positive predictive value), parameters used in cost-effectiveness analysis, pathologic and biological characteristics of screen-detected 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional digital mammography. | Device | — | UNRESOLVED |
| DBT | Device | — | UNRESOLVED |
| Invitation for breast screening and random allocation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Digital Breast Tomosynthesis - DBT
- description
- Invitation for breast screening and random allocation. Participants randomised to DBT will be screened with bilateral, two-view combo mode (DBT images are obtained with DM images). DBT participants will have an additional radiation exposure for the combined DM and DBT examinations.
- interventionNames
- Other: Invitation for breast screening and random allocation
- Device: DBT
- type
- ACTIVE_COMPARATOR
- label
- Conventional digital mammography - DM
- description
- Invitation for breast screening and random allocation. Participants randomised to DM will be screened with bilateral, two-view DM.
- interventionNames
- Other: Invitation for breast screening and random allocation
- Device: Conventional digital mammography.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 46 Years
- Maximum age
- 68 Years
Show eligibility criteria text
Inclusion Criteria: * Asymptomatic women 45-68 years, residents in the Piedmont Region, attending the regional breast cancer screening program Exclusion Criteria: * Personal history of breast cancer * A terminal illness * Patients who are unable to give informed consent * Breast implants
References
Publications (0)
Data not yet available