Clinical trial · Observational
Tomosynthesis in the Oslo Breast Cancer Screening Program
Digital Breast Tomosynthesis in the Oslo Mammography 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)
The Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will include women aged 50 to 69 years invited to the population-based mammography-screening program. All women attending the screening unit will be asked if they want to attend the trial. If so, they will be informed about the project, the technique, and the additional compression and radiation dose. All mammographic examinations of women attending the trial will be independently interpreted by four radiologists. Since the trial is part of the official Norwegian Breast Cancer Screening Program (NBCSP), the interpretations will be carried out on-line into the national screening database of the NBCSP. The study will include independent reading of conventional digital (2D) mammograms, 2D plus computer-aided detection (CAD), 2D plus DBT, and synthetic 2D plus DBT. There will be a common consensus meeting for all examinations having a positive score. Recalls and diagnostic work-up will be according to daily practice at the Oslo University Hospital Ullevaal and the guidelines of the NBCSP. Outcome measures will use performance indicators for organized screening programs, including recall rate, false positive scores, cancer detection rate, positive predictive values, and cancer characteristics for the individual readers of the trial.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Detection Rate | Breast Neoplasm | PROBABILISTIC | 0.70 |
| False Positive Rate | — | UNRESOLVED | — |
| Positive Predictive Value | — | UNRESOLVED | — |
| Recall Rate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital breast tomosynthesis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Digital mammography
- interventionNames
- Procedure: Digital breast tomosynthesis
Primary outcomes (1)
- measure
- Screening performance indicators
- timeFrame
- From Nov. 22, 2010 to Dec. 31, 2012
Secondary outcomes (1)
- measure
- Interval cancer rate
- timeFrame
- From Nov. 23, 2010 to Dec. 31, 2014
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Women 50 to 69 years who have signed the informed consent Exclusion Criteria: * Women with pacemaker, implants, and severely disabled
References
Publications (2)
- DERIVEDSkaane P, Sebuodegard S, Bandos AI, Gur D, Osteras BH, Gullien R, Hofvind S. Performance of breast cancer screening using digital breast tomosynthesis: results from the prospective population-based Oslo Tomosynthesis Screening Trial. Breast Cancer Res Treat. 2018 Jun;169(3):489-496. doi: 10.1007/s10549-018-4705-2. Epub 2018 Feb 10. PMID 29429017
- DERIVEDSkaane 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