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The Tomosynthesis Trial in Bergen - Part 2 (To-Be 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669926
Recruitment Status : Active, not recruiting
First Posted : September 13, 2018
Last Update Posted : February 24, 2020
Sponsor:
Collaborators:
Haukeland University Hospital
University of Oslo
Norwegian Cancer Society
Information provided by (Responsible Party):
Cancer Registry of Norway

Tracking Information
First Submitted Date  ICMJE September 3, 2018
First Posted Date  ICMJE September 13, 2018
Last Update Posted Date February 24, 2020
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
Compare rates of screen detected breast cancer after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
Rate of screening detected breast cancer, among those screened
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
  • Compare recall rates after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Rate of recalled women due to mammographic findings, among those screened
  • Positive predictive value of recalls after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Rate of breast cancer cases among those recalled
  • Prognostic and predictive tumor characteristics for screening detected breast cancer after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Distribution of characteristics among the women diagnosed with breast cancer
  • Rate of interval breast cancer following screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Rates and prognostic and predictive tumor characteristics of interval cancer among women screened in To-Be 1, stratified by mammographic density.
  • Rate of missed and true screen-detected and interval breast cancer in mammographic screening with DBT+SM versus DM. [ Time Frame: 24-48 month after start up of the trial ]
    Retrospective review of prior and actual mammograms from women with interval and screen-detected breast cancers detected in To-Be 1 and 2, respectively.
  • Economical aspects of continuous use of DBT+SM [ Time Frame: 48 months from start up of the trial ]
    Estimation of the financial impact of running a screening program with DBT+SM in an everyday setting.
  • Comparing interpretation times to investigate possible learning effects when reading DBT+SM in two consecutive screening rounds [ Time Frame: 48 months from start up of the trial ]
    Evaluation of difference in interpretation time for subsequent versus prevalent DBT+SM screens
  • Assessing degree of experienced and expected pain in DBT+SM screening by compression pressure using questionnaire [ Time Frame: 6 to 48 months after start up of the trial ]
    Explore whether individualized, standardized compression pressure influences women's screening experiences using a numeric rating scale (0 "No discomfort/pain" to 10 "Very much discomfort/pain"). Drafting of the questionnaire is in progress.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
  • Compare recall rates after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Rate of recalled women due to mammographic findings, among those screened
  • Positive predictive value of recalls after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Rate of breast cancer cases among those recalled
  • Prognostic and predictive tumor characteristics for screening detected breast cancer after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Distribution of characteristics among the women diagnosed with breast cancer
  • Rate of interval breast cancer following screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Rates and prognostic and predictive tumor characteristics of interval cancer among women screened in To-Be 1, stratified by mammographic density.
  • Rate of missed and true screen-detected and interval breast cancer in mammographic screening with DBT+SM versus DM. [ Time Frame: 24-48 month after start up of the trial ]
    Retrospective review of prior and actual mammograms from women with interval and screen-detected breast cancers detected in TOBE-1 and -2, respectively.
  • Economical aspects of continuous use of DBT+SM [ Time Frame: 48 months from start up of the trial ]
    Estimation of the financial impact of running a screening program with DBT+SM in an everyday setting.
  • Comparing interpretation times to investigate possible learning effects when reading DBT+SM in two consecutive screening rounds [ Time Frame: 48 months from start up of the trial ]
    Evaluation of difference in interpretation time for subsequent versus prevalent DBT+SM screens
  • Assessing degree of experienced and expected pain in DBT+SM screening by compression pressure using questionnaire [ Time Frame: 6 to 48 months after start up of the trial ]
    Explore whether individualized, standardized compression pressure influences women's screening experiences
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Tomosynthesis Trial in Bergen - Part 2
Official Title  ICMJE Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?
Brief Summary The aim of the study is to compare early performance measures and economic aspects of organized breast cancer screening for women screened using digital breast tomosynthesis+synthetic mammography (DBT+SM) to women with a prior DBT+SM or digital mammography (DM) from To-Be 1 (NCT02835625).
Detailed Description

Digital breast tomosynthesis (DBT) is a new "three-dimensional" screening tool for breast cancer, claimed to be superior to standard two-dimensional (2D) digital mammography (DM) based on results of lower or similar recall rate, and a 30-50% higher rate of screen-detected breast cancer for DBT compared to DM.

The Bergen Tomosynthesis Trial (To-Be) is a randomized controlled trial investigating whether DBT, including synthetic mammography (SM), is superior for breast cancer screening to DM (ClinicalTrials.gov Identifier: NCT02835625) - hereafter referred to as To-Be 1. The study is run as part of BreastScreen Norway (inviting women aged 50-69 to screening every two years). It started in October 2015 and finished recruitment in December 2017, after two years - one screening round - of data collection.

Results from To-Be 1 will fill some of the knowledge gaps regarding DBT+SM in screening. However, running To-Be 1 and recent publications on the topic have identified additional challenges and new evidence gaps that are important to address before DBT can be considered for use in organized screening. Thus, the To-Be trail will be extended with five more year (To-Be 2), consisting of one additional screening round (two years) where all women in the study population are screened with DBT+SM with a three year follow-up.

To investigate the effect of subsequent screening with DBT+SM all women attending mammography screening in Bergen in 2018 and 2019 will be screened with DBT+SM. To-Be 2 is a prospective cohort study targeting 32 000 women, and all women attending screening will be asked if they are willing to take part in the study after receiving written and oral information about the study. Women willing to participate in the study will sign an informed consent form. We expect a participation rate of 90%. The participating women will be screened with DBT+SM. Women not willing to participate in the study will be screened with DM, and not included in our study.

Continuing To-Be 1 with To-Be 2 is the only opportunity to get information on women subsequently screened with DBT+SM, that have a prior DBT+SM or DM based on random allocation. This will also allow the investigators to analyze data on interval breast cancer among women screened with DBT+SM after DBT+SM and with DBT+SM after DM in To-Be 1 in 2020.

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

Part I: Early performance measures for screening with DBT+SM after DBT+SM, and DBT+SM after DM.

Part II: Interval breast cancer following screening with DBT+SM versus DM, focusing on interval breast cancers identified among women screened in To-Be 1.

Part III: Missed and true screen-detected and interval breast cancer in mammographic screening with DBT+SM versus DM.

Part IV: Expected and experienced discomfort and pain in DBT+SM by compression force and pressure.

Part V: Economic evaluation of continuous use of DBT.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE Radiation: Digital Breast Tomosynthesis+synthetic mammography
Two-view tomosynthesis performed with GE Senographe Pristina.
Other Name: DBT+SM
Study Arms  ICMJE DBT+SM
Digital Breast Tomosynthesis+synthetic mammography (DBT+SM) All women are screened with DBT+SM. All examinations are independently double read. Consensus used to decide whether or not to recall.
Intervention: Radiation: Digital Breast Tomosynthesis+synthetic mammography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 21, 2020)
31082
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2018)
32400
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written, informed consent to participation

Exclusion Criteria:

  • No written, informed consent to participation
  • Breast implants
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only women are invited to breast cancer screening in BreastScreenn Norway.
Ages  ICMJE 48 Years to 71 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03669926
Other Study ID Numbers  ICMJE 17/209
190184-2017 ( Other Grant/Funding Number: Norwegian Cancer Society )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We will not share the data outside the project group
Responsible Party Cancer Registry of Norway
Study Sponsor  ICMJE Cancer Registry of Norway
Collaborators  ICMJE
  • Haukeland University Hospital
  • University of Oslo
  • Norwegian Cancer Society
Investigators  ICMJE
Principal Investigator: Solveig Hofvind, Professor Cancer Registry of Norway
PRS Account Cancer Registry of Norway
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP