Tomosynthesis in the Oslo Breast Cancer Screening Program

• Conditions: Recall Rate; Cancer Detection Rate; False Positive Rate; Positive Predictive Value
• Interventions: Procedure: Digital breast tomosynthesis

• Registration Number: NCT01248546
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Primary Completion: 2012-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-05
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25000

Inclusion Criteria

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

Exclusion Criteria

• Women with pacemaker, implants, and severely disabled

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Digital mammography	Digital breast tomosynthesis	-

Primary Outcome Measures

Name	Time	Method
Screening performance indicators	From Nov. 22, 2010 to Dec. 31, 2012

Secondary Outcome Measures

Name	Time	Method
Interval cancer rate	From Nov. 23, 2010 to Dec. 31, 2014

Trial Locations

Locations (1)

Oslo University Hospital, Ulleval; 🇳🇴 Oslo, Norway