N/A
N=29,453
The Digital Breast Tomosynthesis Trial in Bergen
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02835625 ↗Enrolled (actual)
29,453
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Number of Participants With Screen-Detected Breast Cancer — 95; 87 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Synthetic Mammography + Digital Breast Tomosynthesis (Radiation); Digital mammography (Radiation)
- Age
- Adult, Older Adult · 48+ yrs
- Sex
- Female
- Sponsor
- Norwegian Institute of Public Health
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Screen-Detected Breast Cancer |
95; 87 | — |
| SECONDARY Number and Percentage of Participants Screen-Detected Breast Cancer Among Participants Recalled for Further Assesment |
95; 87 | — |
| SECONDARY Number of Participants Recalled for Further Assesment Due to Mammographic Findings |
444; 571 | — |
| SECONDARY Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography |
8.5; 6.2 | — |
| SECONDARY Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer |
62; 51; 6; 13; 2; 4 | — |
| SECONDARY Number of Participants With Interval Breast Cancer |
20; 29 | — |
Summary
Compare synthetic mammography+digital breast tomosynthesis (SM+DBT) with digital mammography (DM) as a screening tool for women aged 50-69 years, invited to participate in the Norwegian Breast Cancer Screening Program at the screening unit in Bergen, Norway, with regard to early performance measures, including prognostic and predictive tumor characteristics, radiation doses and cost-effectiveness.
Eligibility Criteria
Inclusion Criteria
- Informed consent
Exclusion Criteria
- Breast implants
Data sourced from ClinicalTrials.gov (NCT02835625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.