Tomosynthesis in the Oslo Breast Cancer Screening Program

Cancer Detection Rate Clinical Trial

— DBT  

Official title:

Digital Breast Tomosynthesis in the Oslo Mammography Screening Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01248546
• Other study ID #: 2010/144 (REK)
• Status: Active, not recruiting
• Phase: N/A
• First received: November 24, 2010
• Last updated: February 4, 2013
• Start date: November 2010
• Est. completion date: September 2015

Study information

• Verified date: February 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: South East D Region Committee for Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25000
• Est. completion date: September 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Women with pacemaker, implants, and severely disabled

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer Detection Rate
• False Positive Rate
• Positive Predictive Value
• Recall Rate

Intervention

Procedure:
• Digital breast tomosynthesis
The participants included in the trial will have an additional radiation exposure for breast tomosynthesis

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ulleval	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Cancer Registry of Norway, Hologic, Inc.

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening performance indicators		From Nov. 22, 2010 to Dec. 31, 2012	No
Secondary	Interval cancer rate		From Nov. 23, 2010 to Dec. 31, 2014	No