Breast CancerMBTSTNCT01091545
Malmö Breast Tomosynthesis Screening Trial
A study testing DBT and FFDM in people with Breast Cancer, run by Region Skane at 1 site in Sweden.
Trial summary
To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM) regarding effectiveness as screening modalities. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DBT and FFDM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2010to 30 Sep 2019
- 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 40 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women 40-74 years old
- in the regular population based mammographic screening program in Malmö, Sweden.
- Exclusion Criteria: pregnancy and women not speaking English or Swedish
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Malmö Breast Screening Unit, Skåne University Hospital
Malmö, SE 20502
About this study
To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM) regarding effectiveness as screening modalities.
Read the detailed description
Mammography is the only approved method for breast cancer screening, but not all tumors can be detected with mammography. The main reason is overlapping structures that can either mimic or hide a tumor on a 2-dimensional image like mammography. Digital breast tomosynthesis, (DBT) is a 3-dimensional x-ray technique that has been developed during the last years. A tomographic technique like DBT, which reduces or eliminates the detrimental effect of over- and underlying tissue, can probably help to find more tumors. This study aims to investigate whether more breast cancers can be detected with DBT compared to full field digital mammography (FFDM) in population invited to screening. An interim analysis will be performed during 2013 including the first 7,500 women of the study cohort.
- Conditions
- Breast Cancer
- Being tested
- DBT and FFDM
- Keywords
- breast cancer, screening, sensitivity, tomosynthesis
- Medical subject headings
- Breast Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT and FFDMRadiation
Women in the study will once undergo both standard FFDM screening (2-views) and DBT (1 view, MLO). This will result in a doubled radiation dose compared to only 2-view FFDM, which is the standard procedure for women in the screening program.
| Study group | Role | What they receive |
|---|---|---|
| FFDM+DBT | Other | Single-armed study. Women are their own controls with paired images of digital mammography and breast tomosynthesis. Receives: Radiation: DBT and FFDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity for breast cancer detection for DBT and DM respectively
Sensitivity and specificity for breast cancer detection will be assessed for DBT and DM respectively. The following screening performance measures will also also investigated: the number of detected cancers per 1000 women screened, the number of recalled women/100 screens (recall rate) after consensus, and the positive predictive value (PPV) for screen-recall and the negative predictive value (NPV), in both reading arms. Analyses of the contribution from different reading steps will be investigated. A follow-up period of 24 months after the intervention period will provide information on the actual numbers of breast cancers in the study population through record linkage with the Swedish Cancer Registry.
Measured: 24 months after trial screening
Secondary outcomes (2)
What kind of cancers are detected and not detected with DBT?
To investigate the biological characteristics of the cancers in the trial by mode of detection (screening detected, interval cancers)
Measured: 24 months after trial screening
Cost-effectiveness of DBT in screening
to investigate the cost-effectiveness of DBT in screening
Measured: 24 months after trial screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study start1 Feb 2010
- Primary completion31 Dec 2017
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Unilabs AB Sweden
- Responsible party
- Sponsor
- Investigators
- Sophia Zackrisson, MD PhD, Principal investigator, Region SkaneIngvar Andersson, MD PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091545
- Sponsor's protocol ID
- Dnr 2009/770
- Acronym
- MBTST
- Status last verified
- Nov 2019
- First submitted
- 12 Mar 2010
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Olinder J, Johnson K, Akesson A, Fornvik D, Zackrisson S. Impact of breast density on diagnostic accuracy in digital breast tomosynthesis versus digital mammography: results from a European screening trial. Breast Cancer Res. 2023 Oct 4;25(1):116. doi: 10.1186/s13058-023-01712-6.
PubMed 37794480Dahlblom V, Andersson I, Lang K, Tingberg A, Zackrisson S, Dustler M. Artificial Intelligence Detection of Missed Cancers at Digital Mammography That Were Detected at Digital Breast Tomosynthesis. Radiol Artif Intell. 2021 Sep 1;3(6):e200299. doi: 10.1148/ryai.2021200299. eCollection 2021 Nov.
PubMed 34870215Zackrisson S, Lang K, Rosso A, Johnson K, Dustler M, Fornvik D, Fornvik H, Sartor H, Timberg P, Tingberg A, Andersson I. One-view breast tomosynthesis versus two-view mammography in the Malmo Breast Tomosynthesis Screening Trial (MBTST): a prospective, population-based, diagnostic accuracy study. Lancet Oncol. 2018 Nov;19(11):1493-1503. doi: 10.1016/S1470-2045(18)30521-7. Epub 2018 Oct 12.
PubMed 30322817
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malmö Breast Tomosynthesis Screening Trial
- ClinicalTrials.gov ID
- NCT01091545
- Acronym / sponsor ID
- MBTST / Dnr 2009/770
- Conditions
- Breast Cancer
- Keywords
- breast cancer, screening, sensitivity, tomosynthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Unilabs AB Sweden
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 24 Mar 2010 (estimated)
- 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.
To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM) regarding effectiveness as screening modalities.
Detailed description
Mammography is the only approved method for breast cancer screening, but not all tumors can be detected with mammography. The main reason is overlapping structures that can either mimic or hide a tumor on a 2-dimensional image like mammography. Digital breast tomosynthesis, (DBT) is a 3-dimensional x-ray technique that has been developed during the last years. A tomographic technique like DBT, which reduces or eliminates the detrimental effect of over- and underlying tissue, can probably help to find more tumors. This study aims to investigate whether more breast cancers can be detected with DBT compared to full field digital mammography (FFDM) in population invited to screening. An interim analysis will be performed during 2013 including the first 7,500 women of the study cohort.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFDM+DBT | Other | Radiation: DBT and FFDMSingle-armed study. Women are their own controls with paired images of digital mammography and breast tomosynthesis. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women 40-74 years old
- in the regular population based mammographic screening program in Malmö, Sweden.
- Exclusion Criteria: pregnancy and women not speaking English or Swedish
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DBT and FFDMWomen in the study will once undergo both standard FFDM screening (2-views) and DBT (1 view, MLO). This will result in a doubled radiation dose compared to only 2-view FFDM, which is the standard procedure for women in the screening program. | Radiation | FFDM+DBT |
Primary outcome
Sensitivity and specificity for breast cancer detection for DBT and DM respectively
Time frame: 24 months after trial screening
Sensitivity and specificity for breast cancer detection will be assessed for DBT and DM respectively. The following screening performance measures will also also investigated: the number of detected cancers per 1000 women screened, the number of recalled women/100 screens (recall rate) after consensus, and the positive predictive value (PPV) for screen-recall and the negative predictive value (NPV), in both reading arms. Analyses of the contribution from different reading steps will be investigated. A follow-up period of 24 months after the intervention period will provide information on the actual numbers of breast cancers in the study population through record linkage with the Swedish Cancer Registry.
2 secondary outcomes
What kind of cancers are detected and not detected with DBT?
Time frame: 24 months after trial screening
Cost-effectiveness of DBT in screening
Time frame: 24 months after trial screening
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 13 Nov 2019.
- Derived from this study: PubMed 37794480Olinder J, Johnson K, Akesson A, Fornvik D, Zackrisson S. Impact of breast density on diagnostic accuracy in digital breast tomosynthesis versus digital mammography: results from a European screening trial. Breast Cancer Res. 2023 Oct 4;25(1):116. doi: 10.1186/s13058-023-01712-6.
- Derived from this study: PubMed 34870215Dahlblom V, Andersson I, Lang K, Tingberg A, Zackrisson S, Dustler M. Artificial Intelligence Detection of Missed Cancers at Digital Mammography That Were Detected at Digital Breast Tomosynthesis. Radiol Artif Intell. 2021 Sep 1;3(6):e200299. doi: 10.1148/ryai.2021200299. eCollection 2021 Nov.
- Derived from this study: PubMed 30322817Zackrisson S, Lang K, Rosso A, Johnson K, Dustler M, Fornvik D, Fornvik H, Sartor H, Timberg P, Tingberg A, Andersson I. One-view breast tomosynthesis versus two-view mammography in the Malmo Breast Tomosynthesis Screening Trial (MBTST): a prospective, population-based, diagnostic accuracy study. Lancet Oncol. 2018 Nov;19(11):1493-1503. doi: 10.1016/S1470-2045(18)30521-7. Epub 2018 Oct 12.
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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.
Sophia Zackrisson, MD PhD principal investigator
Region Skane
Ingvar Andersson, MD PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT and FFDM in people with Breast Cancer, run by Region Skane at 1 site in Sweden.
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 4 inclusion and 0 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 13 Nov 2019. 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 Sweden. 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?
Sensitivity and specificity for breast cancer detection for DBT and DM respectively (time frame: 24 months after trial screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01091545, which also lists 3 linked publications.
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 13 Nov 2019.