Clinical trial · Interventional
Digital Breast Tomosynthesis for the Dutch National Breast Cancer Screening Program
- 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)
Digital breast tomosynthesis (DBT) creates a digital pseudo- three-dimensional image of the breast similar to mammography. This gives the screening radiologist more information about a possible abnormality. As a result, breast cancer can be found earlier, but more women might need to be recalled. In the STREAM study, the aim is to identify the impact of DBT on the screen-detected cancer and recall rates, and on interval and advanced cancer rates in 18,200 women after two rounds of screening. For comparison, a control group of about 86,400 women will be selected from the database of the national screening program. Women, screening radiographers, and screening radiologists will be asked whether they find this new screening technique acceptable. Furthermore, the optimal strategy for screening radiologists to read the DBT images will be identified and the cost-effectiveness of screening with DBT will be determined. The images and data will be stored in a database for future research. Expected outcome: As a result of this project, the researchers will have shown if breast cancer screening with DBT in the Netherlands should be implemented or not. It will also be demonstrated, were it to be introduced, how it should be implemented, having addressed all the remaining questions, and having found the optimal DBT workflow specifically for a high-volume population-based screening program.
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 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Breast Tomosynthesis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- 18200 participants who will be screened with tomosynthesis instead of digital mammography. All participants will be asked to participate in the study for 2 screening rounds. The number of participants for the second round will be less, due to drop-outs.
- interventionNames
- Diagnostic Test: Digital Breast Tomosynthesis
Primary outcomes (1)
- measure
- The effect of DBT screening on breast cancers diagnosed at an advanced stage at screening or in between rounds of screening. (detection rate of stage II+ cancers per 1000 screens and interval cancer rate per 1000 screens)
- timeFrame
- 5 years
- description
- The outcome will be compared to the control group (DM)
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * Women who are invited to participate to the Dutch Breast Cancer Screening program in the age group 50-72 years.. Exclusion Criteria: * Disabled women * Women who are wheelchair bound
References
Publications (0)
Data not yet available