The Digital Breast Tomosynthesis Trial in Bergen
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      DBT is a new screening tool, argued to be better than standard DM. This statement is based on
      a lower recall rate, and a higher rate of early-stage screen-detected cancer. No studies have
      so far reported results from women screened with DBT from GE Healthcare, as far as the
      investigators know. DBT from GE offer synthetic two-dimensional DM generated from the DBT
      data (SM), and studies have shown similar detection rates for this technique as of adjacent
      DM. By comparing results of early performance measures and economic aspects in two comparable
      populations of women in the same age group, residing in the same county, the investigators
      can measure the effect of SM+DBT versus standard DM with equipment from GE Healthcare. The
      populations will be examined by the same radiographers, screen-read by the same radiologists,
      histologically breast cancer proven by the same pathologists, and treated by the same
      surgeons and oncologists.

      A prospective cohort study targeting 45,000 women invited to breast cancer screening in
      Bergen, Hordaland in the study period, 2016-2018, will be performed. A screening
      participation of approximately 75% is expected. All attending women will be asked if they are
      willing to participate in the study after receiving written and oral information about the
      study. Women willing to participate in the study will sign an informed consent. Of the
      attending women it is expected that about 90-95% will consent to participate in the study.
      The women will be randomized into two groups, a study group and a control group. The
      randomization will take place at the screening unit in Bergen. The outcome of the
      randomization is based on the 11-digit personal identification number assigned to every
      citizen in Norway. In the study group, the women will be screened with SM+DBT. In the control
      group, the women will be screened with DM. Women not willing to participate in the study will
      be screened with DM, and not included in our study.

      The investigators aim to address the following topics and research questions:

        -  Study 1: Early performance measures in a population based screening program using SM+DBT
           versus DM - interim analyses.

        -  Study 2: Use of SM+DBT versus DM in a population based screening program - a randomized
           controlled trial.

        -  Study 3: Prognostic and predictive histopathologic characteristics of breast tumors
           detected in a population based program using SM+DBT versus DM.

        -  Study 4: SM+DBT and DM in a populations based screening program - which technology has
           the highest sensitivity for women with mammographic dense breast?

        -  Study 5 and 6: Costs of SM+DBT and DM in a populations based screening program - is
           SM+DBT cost-effective?
    

Intervention name(s): Synthetic Mammography + Digital Breast Tomosynthesis; Digital mammography
Intervention type(s): Radiation; Radiation
Intervention description(s): Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis.; Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis.
Other intervention name(s): SM+DBT; DM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diagnostic Imaging; Mammography; Randomized Controlled Trial; Tomosynthesis; Early performance measures; Recall; Radiation dose; Cancer detection; Sensitivity; Specificity; Cost; Economy