Cancer Detection Rate Clinical Trial
Official title:
Digital Breast Tomosynthesis in the Oslo Mammography Screening Program
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective