Tomosynthesis in the Oslo Breast Cancer Screening Program (DBT)
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|ClinicalTrials.gov Identifier: NCT01248546|
Recruitment Status : Unknown
Verified February 2013 by Per Skaane, Oslo University Hospital.
Recruitment status was: Active, not recruiting
First Posted : November 25, 2010
Last Update Posted : February 5, 2013
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 or disease||Intervention/treatment|
|Recall Rate Cancer Detection Rate False Positive Rate Positive Predictive Value||Procedure: Digital breast tomosynthesis|
|Study Type :||Observational|
|Estimated Enrollment :||25000 participants|
|Official Title:||Digital Breast Tomosynthesis in the Oslo Mammography Screening Program|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||September 2015|
Procedure: Digital breast tomosynthesis
The participants included in the trial will have an additional radiation exposure for breast tomosynthesis
- Screening performance indicators [ Time Frame: From Nov. 22, 2010 to Dec. 31, 2012 ]
- Interval cancer rate [ Time Frame: From Nov. 23, 2010 to Dec. 31, 2014 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248546
|Oslo University Hospital, Ulleval|
|Oslo, Norway, 0407|