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Tomosynthesis in the Oslo Breast Cancer Screening Program (DBT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Cancer Registry of Norway
Hologic, Inc.
Information provided by (Responsible Party):
Per Skaane, 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.

Condition or disease Intervention/treatment
Recall Rate Cancer Detection Rate False Positive Rate Positive Predictive Value Procedure: Digital breast tomosynthesis

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Study Type : Observational
Estimated Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Group/Cohort Intervention/treatment
Digital mammography Procedure: Digital breast tomosynthesis
The participants included in the trial will have an additional radiation exposure for breast tomosynthesis

Primary Outcome Measures :
  1. Screening performance indicators [ Time Frame: From Nov. 22, 2010 to Dec. 31, 2012 ]

Secondary Outcome Measures :
  1. Interval cancer rate [ Time Frame: From Nov. 23, 2010 to Dec. 31, 2014 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Inclusion Criteria:

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

Exclusion Criteria:

  • Women with pacemaker, implants, and severely disabled

Information from the National Library of Medicine

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 identifier (NCT number): NCT01248546

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Oslo University Hospital, Ulleval
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
Cancer Registry of Norway
Hologic, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Per Skaane, professor dr. med., Oslo University Hospital Identifier: NCT01248546    
Other Study ID Numbers: 2010/144 (REK)
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013
Keywords provided by Per Skaane, Oslo University Hospital:
Breast cancer
Computer-aided detection
Mammography screening
Digital breast tomosynthesis