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
  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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Screening performance indicators [ Time Frame: From Nov. 22, 2010 to Dec. 31, 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248546

Locations
Norway
Oslo University Hospital, Ulleval
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
The Norwegian Cancer Registry
Hologic, Inc.
  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 August 18, 2014