Breast NeoplasmsTo-Be 2NCT03669926
The Tomosynthesis Trial in Bergen - Part 2
A study testing Digital Breast Tomosynthesis+synthetic mammography in people with Breast Neoplasms, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 48 to 71 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Digital Breast Tomosynthesis+synthetic mammography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31,082 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2018to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 71 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written, informed consent to participation
Who cannot join
- No written, informed consent to participation
- Breast implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?
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).
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Digital Breast Tomosynthesis+synthetic mammography
- Keywords
- Diagnostic Imaging, Mammography, Tomosynthesis, Breast cancer screening, Subsequent screening, Cancer detection, Cost effectiveness, Early performance measures, Interval cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Breast Tomosynthesis+synthetic mammographyRadiation
Also called DBT+SM
Two-view tomosynthesis performed with GE Senographe Pristina.
| Study group | Role | What they receive |
|---|---|---|
| DBT+SM | Other | 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. Receives: Radiation: Digital Breast Tomosynthesis+synthetic mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Rate of screening detected breast cancer, among those screened
Measured: 48 months from start up of the trial
Secondary outcomes (8)
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.
Rate of recalled women due to mammographic findings, among those screened
Measured: 48 months from start up of the trial
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.
Rate of breast cancer cases among those recalled
Measured: 48 months from start up of the trial
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.
Distribution of characteristics among the women diagnosed with breast cancer
Measured: 48 months from start up of the trial
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.
Rates and prognostic and predictive tumor characteristics of interval cancer among women screened in To-Be 1, stratified by mammographic density.
Measured: 48 months from start up of the trial
Rate of missed and true screen-detected and interval breast cancer in mammographic screening with DBT+SM versus DM.
Retrospective review of prior and actual mammograms from women with interval and screen-detected breast cancers detected in To-Be 1 and 2, respectively.
Measured: 24-48 month after start up of the trial
Economical aspects of continuous use of DBT+SM
Estimation of the financial impact of running a screening program with DBT+SM in an everyday setting.
Measured: 48 months from start up of the trial
Comparing interpretation times to investigate possible learning effects when reading DBT+SM in two consecutive screening rounds
Evaluation of difference in interpretation time for subsequent versus prevalent DBT+SM screens
Measured: 48 months from start up of the trial
Assessing degree of experienced and expected pain in DBT+SM screening by compression pressure using questionnaire
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.
Measured: 6 to 48 months after start up of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Jan 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31,082 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital, University of Oslo, Norwegian Cancer Society
- Responsible party
- Sponsor
- Investigators
- Solveig Hofvind, Professor, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669926
- Sponsor's protocol ID
- 17/209
- Other IDs
- 190184-2017
- Acronym
- To-Be 2
- Status last verified
- Sep 2023
- First submitted
- 3 Sep 2018
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share the data outside the project group
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?
- ClinicalTrials.gov ID
- NCT03669926
- Acronym / sponsor ID
- To-Be 2 / 17/209
- Conditions
- Breast Neoplasms
- Keywords
- Diagnostic Imaging, Mammography, Tomosynthesis, Breast cancer screening, Subsequent screening, Cancer detection, Cost effectiveness, Early performance measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31,082 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Haukeland University Hospital, University of Oslo, Norwegian Cancer Society
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBT+SM | Other | Radiation: Digital Breast Tomosynthesis+synthetic mammographyDigital 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. |
Who may qualify
- Ages
- 48 to 71 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Written, informed consent to participation
Key exclusion criteria (2 listed)
- No written, informed consent to participation
- Breast implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Breast Tomosynthesis+synthetic mammographyAlso: DBT+SMTwo-view tomosynthesis performed with GE Senographe Pristina. | Radiation | DBT+SM |
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
Economical aspects of continuous use of DBT+SM
Time frame: 48 months from start up of the trial
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No. We will not share the data outside the project group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Solveig Hofvind, Professor principal investigator
Norwegian Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Breast Tomosynthesis+synthetic mammography in people with Breast Neoplasms, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.