Overview

This trial is active, not recruiting.

Conditions recall rate, cancer detection rate, false positive rate, positive predictive value
Treatment digital breast tomosynthesis
Sponsor Oslo University Hospital
Collaborator The Norwegian Cancer Registry
Start date November 2010
End date December 2012
Trial size 25000 participants
Trial identifier NCT01248546, 2010/144 (REK)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
digital breast tomosynthesis
The participants included in the trial will have an additional radiation exposure for breast tomosynthesis

Primary Outcomes

Measure
Screening performance indicators
time frame: From Nov. 22, 2010 to Dec. 31, 2012

Secondary Outcomes

Measure
Interval cancer rate
time frame: From Nov. 23, 2010 to Dec. 31, 2014

Eligibility Criteria

Female participants from 50 years up to 69 years old.

Inclusion Criteria: - Women 50 to 69 years who have signed the informed consent Exclusion Criteria: - Women with pacemaker, implants, and severely disabled

Additional Information

Official title Digital Breast Tomosynthesis in the Oslo Mammography Screening Program
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Oslo University Hospital.