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The Tomosynthesis Trial in Bergen (TOBE)

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ClinicalTrials.gov Identifier: NCT02835625
Recruitment Status : Active, not recruiting
First Posted : July 18, 2016
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
Haukeland University Hospital
University of Oslo
The Research Council of Norway
Information provided by (Responsible Party):
Cancer Registry of Norway

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Radiation: Synthetic Mammography + Digital Breast Tomosynthesis Radiation: Digital mammography Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?
Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: DM


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of rates of screening detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program. [ Time Frame: 36 months from start up of the trial ]
    Rate of screening detected breast cancer, among those screened


Secondary Outcome Measures :
  1. Positive predictive value of recalls among those screened with tomosynthesis versus digital mammography in a population based screening program. [ Time Frame: 36 months from start up of the trial ]
    Rate of breast cancer cases among those recalled

  2. Comparison of recall rates in tomosynthesis versus digital mammography as performed in a population based screening program. [ Time Frame: 36 months from start up of the trial ]
    Rate of recalled women due to mammographic findings, among those screened

  3. Economical aspects of running an organized screening program with tomosynthesis versus digital mammography [ Time Frame: 36 months from start up of the trial ]
    The economical costs of time spent on reading and recalls, diagnostics and treatment for women screened with tomosynthesis versus digital mammography will be compared

  4. Prognostic and predictive tumor characteristics for screening detected breast cancer detected among those screened with tomosynthesis versus digital mammography in a population based screening program. [ Time Frame: 36 months from start up of the trial ]
    Distribution of characteristics among the women diagnosed with breast cancer

  5. Comparison of rates of interval breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program. [ Time Frame: 60 months from start up of the trial ]
    Rate of interval breast cancer among those screened


Other Outcome Measures:
  1. Time spent on reading screening mammograms and consensus meeting for tomosynthesis versus digital mammography [ Time Frame: 24 months from start up of the trial ]
    The time spent on reading will be compared

  2. Mammographic features in screening detected breast cancer detected among those screened with tomosynthesis versus digital mammography in a population based screening program. [ Time Frame: 36 months from start up of the trial ]
    Distribution of characteristics among the women diagnosed with breast cancer

  3. Radiation doses in tomosynthesis versus digital mammography [ Time Frame: 24 months from start up of the trial ]
    Radiation doses will be measured by an automated software, in mSv


Eligibility Criteria
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Ages Eligible for Study:   48 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent

Exclusion Criteria:

  • Breast implants
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835625


Locations
Norway
Haukeland University Hospital
Bergen, Hordaland, Norway, 0521
Cancer Registry of Norway
Oslo, Norway, 0379
Sponsors and Collaborators
Cancer Registry of Norway
Haukeland University Hospital
University of Oslo
The Research Council of Norway
Investigators
Principal Investigator: Solveig Hofvind, Professor Cancer Registry of Norway
  Study Documents (Full-Text)

Documents provided by Cancer Registry of Norway:
Study Protocol and Statistical Analysis Plan  [PDF] August 14, 2015

More Information
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Publications:

Responsible Party: Cancer Registry of Norway
ClinicalTrials.gov Identifier: NCT02835625     History of Changes
Other Study ID Numbers: 247941/H10
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not share the data outside the project group

Keywords provided by Cancer Registry of Norway:
Diagnostic Imaging
Mammography
Randomized Controlled Trial
Tomosynthesis
Early performance measures
Recall
 Radiation dose
Cancer detection
Sensitivity
Specificity
Cost
Economy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases