The Digital Breast Tomosynthesis Trial in Bergen (TOBE)

August 26, 2024 updated by: Norwegian Institute of Public Health

Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?

Compare synthetic mammography+digital breast tomosynthesis (SM+DBT) with digital mammography (DM) as a screening tool for women aged 50-69 years, invited to participate in the Norwegian Breast Cancer Screening Program at the screening unit in Bergen, Norway, with regard to early performance measures, including prognostic and predictive tumor characteristics, radiation doses and cost-effectiveness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

DBT is a new screening tool, argued to be better than standard DM. This statement is based on a lower recall rate, and a higher rate of early-stage screen-detected cancer. No studies have so far reported results from women screened with DBT from GE Healthcare, as far as the investigators know. DBT from GE offer synthetic two-dimensional DM generated from the DBT data (SM), and studies have shown similar detection rates for this technique as of adjacent DM. By comparing results of early performance measures and economic aspects in two comparable populations of women in the same age group, residing in the same county, the investigators can measure the effect of SM+DBT versus standard DM with equipment from GE Healthcare. The populations will be examined by the same radiographers, screen-read by the same radiologists, histologically breast cancer proven by the same pathologists, and treated by the same surgeons and oncologists.

A prospective cohort study targeting 45,000 women invited to breast cancer screening in Bergen, Hordaland in the study period, 2016-2018, will be performed. A screening participation of approximately 75% is expected. All attending women will be asked if they are willing to participate in the study after receiving written and oral information about the study. Women willing to participate in the study will sign an informed consent. Of the attending women it is expected that about 90-95% will consent to participate in the study. The women will be randomized into two groups, a study group and a control group. The randomization will take place at the screening unit in Bergen. The outcome of the randomization is based on the 11-digit personal identification number assigned to every citizen in Norway. In the study group, the women will be screened with SM+DBT. In the control group, the women will be screened with DM. Women not willing to participate in the study will be screened with DM, and not included in our study.

The investigators aim to address the following topics and research questions:

  • Study 1: Early performance measures in a population based screening program using SM+DBT versus DM - interim analyses.
  • Study 2: Use of SM+DBT versus DM in a population based screening program - a randomized controlled trial.
  • Study 3: Prognostic and predictive histopathologic characteristics of breast tumors detected in a population based program using SM+DBT versus DM.
  • Study 4: SM+DBT and DM in a populations based screening program - which technology has the highest sensitivity for women with mammographic dense breast?
  • Study 5 and 6: Costs of SM+DBT and DM in a populations based screening program - is SM+DBT cost-effective?

Study Type

Interventional

Enrollment (Actual)

29453

Phase

  • Not Applicable

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, 0379
        • Cancer Registry of Norway
    • Hordaland
      • Bergen, Hordaland, Norway, 0521
        • Haukeland University Hospital

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

48 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Informed consent

Exclusion Criteria:

  • Breast implants

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Digital Breast Tomosynthesis

Synthetic Mammography (SM) + Digital Breast Tomosynthesis (DBT)

The SM+DBT will be independently read by two radiologists. A consensus meeting will decide whether to recall the woman or not.

Women selected for further assessment (positive screening exam) will be recalled.
Radiation: Synthetic Mammography + Digital Breast Tomosynthesis
Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis.
Other Names:
  • SM+DBT
Active Comparator: Digital mammography
The digital mammograms will be independently read by two radiologists. A consensus meeting will decide whether to recall the woman or not.
Radiation: Digital mammography
Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis.
Other Names:
  • DM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Screen-Detected Breast Cancer
Time Frame: 36 months from start up of the trial
Comparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.
36 months from start up of the trial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Percentage of Participants Screen-Detected Breast Cancer Among Participants Recalled for Further Assesment
Time Frame: 36 months from start up of the trial
Positive predictive value of recalls (number of screen-detected breast cancer among participants recalled for further assesment) for tomosynthesis versus digital mammography in a population based screening program.
36 months from start up of the trial
Number of Participants Recalled for Further Assesment Due to Mammographic Findings
Time Frame: 36 months from start up of the trial
Comparison of rate of recall for further assesment due to mammographic findings in tomosynthesis versus digital mammography as performed in a population based screening program.
36 months from start up of the trial
Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography
Time Frame: 36 months from start up of the trial
The incremental cost per woman screened with digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening program.
36 months from start up of the trial
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Time Frame: 36 months from start up of the trial
Distribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.
36 months from start up of the trial
Number of Participants With Interval Breast Cancer
Time Frame: 60 months from start up of the trial
Rate of interval breast cancer among those screened with tomosynthesis versus digital mammography as performed in a population based screening program.
60 months from start up of the trial

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Spent on Screen-Reading and Consensus Meetings
Time Frame: 24 months from start up of the trial
The time spent on screen-reading and consensus will be compared for tomosynthesis versus digital mammography
24 months from start up of the trial
Mammographic Features of Screen-Detected Breast Cancer
Time Frame: 36 months from start up of the trial
Distribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.
36 months from start up of the trial
Radiation Doses When Screening With Tomosynthesis Versus Digital Mammography
Time Frame: 24 months from start up of the trial
Radiation doses will be measured for screening with tomosynthesis and digital mammography by an automated software, in milligray (mGy).
24 months from start up of the trial

Collaborators and Investigators

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

Sponsor

Norwegian Institute of Public Health

Collaborators

University of Oslo
The Research Council of Norway
Haukeland University Hospital

Investigators

  • Principal Investigator: Solveig Hofvind, Professor, Norwegian Institute of Public Health

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 (Actual)

January 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimated)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 247941/H10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not share the data outside the project group

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.

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