Clinical trial NCT01248546: Tomosynthesis in the Oslo Breast Cancer Screening Program
Official title: Digital Breast Tomosynthesis in the Oslo Mammography Screening Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recall Rate
Cancer Detection Rate
False Positive Rate
Positive Predictive Value
Keywords: Breast cancer
Computer-aided detection
Mammography screening
Digital breast tomosynthesis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Institute of Public Health
name: Hologic, Inc.
First posted: 2010-11-25
Enrollment: 25000
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 50 to 69 years attending the national breast cancer screening program who sign an informed consent regarding participation in the trial

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Women 50 to 69 years who have signed the informed consent

Exclusion Criteria:

* Women with pacemaker, implants, and severely disabled

Primary outcomes:
measure: Screening performance indicators
timeFrame: From Nov. 22, 2010 to Dec. 31, 2012
Secondary outcomes:
measure: Interval cancer rate
timeFrame: From Nov. 23, 2010 to Dec. 31, 2014
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ulleval
Study officials:
References:
citation: Skaane 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.
citation: Skaane 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.