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Tomosynthesis in the Oslo Breast Cancer Screening Program (DBT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Norwegian Cancer Registry
Hologic, Inc.
Information provided by (Responsible Party):
Per Skaane, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01248546
First received: November 24, 2010
Last updated: February 4, 2013
Last verified: February 2013

November 24, 2010
February 4, 2013
November 2010
December 2012   (final data collection date for primary outcome measure)
Screening performance indicators [ Time Frame: From Nov. 22, 2010 to Dec. 31, 2012 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01248546 on ClinicalTrials.gov Archive Site
Interval cancer rate [ Time Frame: From Nov. 23, 2010 to Dec. 31, 2014 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Tomosynthesis in the Oslo Breast Cancer Screening Program
Digital Breast Tomosynthesis in the Oslo Mammography Screening Program

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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

  • Recall Rate
  • Cancer Detection Rate
  • False Positive Rate
  • Positive Predictive Value
Procedure: Digital breast tomosynthesis
The participants included in the trial will have an additional radiation exposure for breast tomosynthesis
Digital mammography
Intervention: Procedure: Digital breast tomosynthesis
Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013 Apr;267(1):47-56. doi: 10.1148/radiol.12121373. Epub 2013 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25000
September 2015
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Women with pacemaker, implants, and severely disabled
Female
50 Years to 69 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01248546
2010/144 (REK)
No
Per Skaane, Oslo University Hospital
Oslo University Hospital
  • The Norwegian Cancer Registry
  • Hologic, Inc.
Not Provided
Oslo University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP