Tomosynthesis in the Oslo Breast Cancer Screening Program (DBT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Recall Rate Cancer Detection Rate False Positive Rate Positive Predictive Value |
Procedure: Digital breast tomosynthesis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Digital Breast Tomosynthesis in the Oslo Mammography Screening Program |
- Screening performance indicators [ Time Frame: From Nov. 22, 2010 to Dec. 31, 2012 ] [ Designated as safety issue: No ]
- Interval cancer rate [ Time Frame: From Nov. 23, 2010 to Dec. 31, 2014 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25000 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | September 2015 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Digital mammography |
Procedure: Digital breast tomosynthesis
The participants included in the trial will have an additional radiation exposure for breast tomosynthesis
|
Eligibility| Ages Eligible for Study: | 50 Years to 69 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Women aged 50 to 69 years attending the national breast cancer screening program who sign an informed consent regarding participation in the trial
Inclusion Criteria:
- Women 50 to 69 years who have signed the informed consent
Exclusion Criteria:
- Women with pacemaker, implants, and severely disabled
Contacts and Locations
More Information
No publications provided by Oslo University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Per Skaane, professor dr. med., Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01248546 History of Changes |
| Other Study ID Numbers: | 2010/144 (REK) |
| Study First Received: | November 24, 2010 |
| Last Updated: | February 4, 2013 |
| Health Authority: | Norway: South East D Region Committee for Research Ethics |
Keywords provided by Oslo University Hospital:
|
Breast cancer Computer-aided detection Mammography screening Digital breast tomosynthesis |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013