Tomosynthesis in the Oslo Breast Cancer Screening Program (DBT)

February 4, 2013 updated by: Per Skaane, Oslo University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Oslo University Hospital, Ullevål

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Women with pacemaker, implants, and severely disabled

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Screening performance indicators
Time Frame: From Nov. 22, 2010 to Dec. 31, 2012
From Nov. 22, 2010 to Dec. 31, 2012

Secondary Outcome Measures

Outcome Measure
Time Frame
Interval cancer rate
Time Frame: From Nov. 23, 2010 to Dec. 31, 2014
From Nov. 23, 2010 to Dec. 31, 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Hologic, Inc.
Cancer Registry of Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ANTICIPATED)

September 1, 2015

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (ESTIMATE)

November 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010/144 (REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recall Rate

Clinical Trials on Digital breast tomosynthesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe