Breast Cancer ScreeningSTREAMNCT06059300
Digital Breast Tomosynthesis for the Dutch National Breast Cancer Screening Program
A study testing Digital Breast Tomosynthesis in people with Breast Cancer Screening, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Digital breast tomosynthesis (DBT) creates a digital pseudo- three-dimensional image of the breast similar to mammography. This gives the screening radiologist more information about a possible abnormality. As a result, breast cancer can be found earlier, but more women might need to be recalled. Read more about this study
- Who is it for?
- Ages 50 to 72 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- Digital Breast Tomosynthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,200 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Jul 2023to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 72 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who are invited to participate to the Dutch Breast Cancer Screening program in the age group 50-72 years..
Who cannot join
- Disabled women
- Women who are wheelchair bound
Trial locations and contacts
1 site in 1 country.
About this study
Digital breast tomosynthesis (DBT) creates a digital pseudo- three-dimensional image of the breast similar to mammography. This gives the screening radiologist more information about a possible abnormality. As a result, breast cancer can be found earlier, but more women might need to be recalled.
In the STREAM study, the aim is to identify the impact of DBT on the screen-detected cancer and recall rates, and on interval and advanced cancer rates in 18,200 women after two rounds of screening. For comparison, a control group of about 86,400 women will be selected from the database of the national screening program. Women, screening radiographers, and screening radiologists will be asked whether they find this new screening technique acceptable. Furthermore, the optimal strategy for screening radiologists to read the DBT images will be identified and the cost-effectiveness of screening with DBT will be determined. The images and data will be stored in a database for future research.
Read more
Expected outcome:
As a result of this project, the researchers will have shown if breast cancer screening with DBT in the Netherlands should be implemented or not. It will also be demonstrated, were it to be introduced, how it should be implemented, having addressed all the remaining questions, and having found the optimal DBT workflow specifically for a high-volume population-based screening program.
Read the detailed description
In the last decade, several large-scale European studies have shown that digital breast tomosynthesis (DBT) increases the detection rate from ~6 to ~9 cancers per 1000 women screened, while the recall rate approaches 3.5% to 4%, independent of the initial recall rate. In the Dutch screening setting with digital mammography (DM), the recall rate is only 2.4%. Therefore, introducing DBT in the Netherlands will likely generate an increase in false positives, but the magnitude of this increase is unknown.
Furthermore, the ~50x increase in the number of images resulting from a DBT exam compared to a DM exam doubles the reading time. For DBT screening in the Netherlands to be feasible from the economic and human resources point of view, the interpretation of these cases must be accelerated, to result in an average reading time comparable to that of reviewing DM exams.
The aim of this project is to make the replacement of DM with DBT in the Dutch National Breast Cancer Screening Program feasible and sustainable, by ensuring its acceptability by the various stakeholders, optimizing the acquisition and reading strategy, determining its expected impact on the national recall rate, and determining its cost-effectiveness. In addition, completion of this project will result in the creation of a DBT-based screening database available for future research.
Work Package (WP) 1 will involve the introduction of DBT in 6 of the 71 screening units in the country to screen 18,200 women for two screening rounds. This study is powered to detect a combined one-third reduction in the interval and advanced cancer rates with DBT screening as the primary endpoint. In addition, as secondary endpoints, the Dutch DBT-based screening recall rates will be determined for the first and second rounds of DBT screening. A contemporary control group of about 86,400 women screened with DM will be selected from the screening database (ScreenIT) of the national screening program. This control group will be selected to reflect the distribution of urban and rural areas as well as the mixture of mobile and fixed units of the screening units selected for the intervention group. In addition, the attendees, and the screening radiographers and radiologists will be surveyed to identify any barriers that limit acceptability of this new modality. Finally, WP1 will also involve the creation of a DBT-based screening database for further research.
In WP2, the optimal DBT reading strategy to be used in the Dutch screening program to minimize the increase in reading time with DBT, will be identified. For this, retrospective observer studies will be performed, using the images from WP1, to test eight different acquisition and reading strategies, some involving the use of cutting-edge artificial intelligence computer systems. These strategies have been shown in initial studies, many performed by the sponsor, to result in a significant reduction in reading time, with no or minimal loss in performance. Once the optimal reading strategies is identified, it will be used to interpret the entire second round of DBT screening acquired in WP1 at the screening reading units retrospectively. In this way, its actual performance and impact on reading time in the real screening environment will be determined.
Finally, in WP3, the results from the other two WPs will be used to model the entire DBT screening program and therefore predict the long-term outcomes and cost-effectiveness of this new screening program. The only method possible to estimate the impact of screening on long-term effects, such as breast cancer mortality and morbidity, as well as cost-effectiveness, is the use of modelling. Therefore, the well-validated MISCAN model will be used, with the data and results gathered, to estimate the long-term impact of DBT screening.
As a result of this project, if successful, breast cancer screening with DBT will be ready for nationwide implementation, having addressed all the country-specific questions and having optimized the DBT workflow specifically for a high-volume population-based screening program.
- Conditions
- Breast Cancer Screening
- Being tested
- Digital Breast Tomosynthesis
- Keywords
- Digital breast tomosynthesis, Acceptability, Reading strategy, Artificial intelligence, Cost-effectiveness, Recall rate, Detection rate, Advanced cancer detection rate, Interval cancer rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Breast TomosynthesisDiagnostic test
Screening with Digital Breast Tomosynthesis instead of Digital Mammography, for two screening rounds
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 18200 participants who will be screened with tomosynthesis instead of digital mammography. All participants will be asked to participate in the study for 2 screening rounds. The number of participants for the second round will be less, due to drop-outs. Receives: Diagnostic Test: Digital Breast Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of DBT screening on breast cancers diagnosed at an advanced stage at screening or in between rounds of screening. (detection rate of stage II+ cancers per 1000 screens and interval cancer rate per 1000 screens)
The outcome will be compared to the control group (DM)
Measured: 5 years
Secondary outcomes (5)
Attendance rate (percentage out of all women invited)
The outcome will be calculated for the intervention group (DBT) and the control group (DM):
Measured: 5 years
Recall (percentage out of all women screened)
The outcome will be calculated for the intervention group (DBT) and the control group (DM):
Measured: 5 years
Cancer detection rate for breast cancer, both invasive and in situ, overall and for cancers stage II or higher (stage II+; per 1000 screened)
The outcome will be calculated for the intervention group (DBT) and the control group (DM):
Measured: 5 years
Positive predictive value for recall (percentage of cancers detected among recalled women)
The outcome will be calculated for the intervention group (DBT) and the control group (DM):
Measured: 5 years
Interval cancer rates (breast cancer detected clinically in the first, second, or third year after a negative screening examination.
The outcome will be calculated for the intervention group (DBT) and the control group (DM):
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start17 Jul 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, UMC Utrecht, LRCB Dutch Expert Centre for Screening, Dutch Breast Cancer Association, University of Sydney, Hologic B.V., Volpara Health Technologies Ltd, Lunit Inc., Screenpoint Medical BV, Sectra Benelux, iCAD, Dutch Foundation of Population Screening
- Responsible party
- Sponsor
- Investigators
- Mireille Broeders, Prof., Principal investigator, Radboud University Medical CenterIoannis Sechopoulos, Prof., Principal investigator, Radboud University Medical CenterNicolien van Ravesteyn, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059300
- Sponsor's protocol ID
- 114374
- Other IDs
- 13710, 5550402130002
- Acronym
- STREAM
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2023
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following end products will be made available for further research and verification: * Summary outcomes of the screening * Methods used during the study such as, but not limited to, data extraction algorithms, statistical analysis, and cost effectiveness
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Breast Tomosynthesis for the Dutch National Breast Cancer Screening Program
- ClinicalTrials.gov ID
- NCT06059300
- Acronym / sponsor ID
- STREAM / 114374
- Conditions
- Breast Cancer Screening
- Keywords
- Digital breast tomosynthesis, Acceptability, Reading strategy, Artificial intelligence, Cost-effectiveness, Recall rate, Detection rate, Advanced cancer detection rate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18,200 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, UMC Utrecht, LRCB Dutch Expert Centre for Screening, Dutch Breast Cancer Association, University of Sydney, Hologic B.V., Volpara Health Technologies Ltd, Lunit Inc., Screenpoint Medical BV, Sectra Benelux, iCAD, Dutch Foundation of Population Screening
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 28 Sep 2023 (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.
Digital breast tomosynthesis (DBT) creates a digital pseudo- three-dimensional image of the breast similar to mammography. This gives the screening radiologist more information about a possible abnormality. As a result, breast cancer can be found earlier, but more women might need to be recalled.
In the STREAM study, the aim is to identify the impact of DBT on the screen-detected cancer and recall rates, and on interval and advanced cancer rates in 18,200 women after two rounds of screening. For comparison, a control group of about 86,400 women will be selected from the database of the national screening program. Women, screening radiographers, and screening radiologists will be asked whether they find this new screening technique acceptable. Furthermore, the optimal strategy for screening radiologists to read the DBT images will be identified and the cost-effectiveness of screening with DBT will be determined. The images and data will be stored in a database for future research.
Expected outcome:
As a result of this project, the researchers will have shown if breast cancer screening with DBT in the Netherlands should be implemented or not. It will also be demonstrated, were it to be introduced, how it should be implemented, having addressed all the remaining questions, and having found the optimal DBT workflow specifically for a high-volume population-based screening program.
Detailed description
In the last decade, several large-scale European studies have shown that digital breast tomosynthesis (DBT) increases the detection rate from ~6 to ~9 cancers per 1000 women screened, while the recall rate approaches 3.5% to 4%, independent of the initial recall rate. In the Dutch screening setting with digital mammography (DM), the recall rate is only 2.4%. Therefore, introducing DBT in the Netherlands will likely generate an increase in false positives, but the magnitude of this increase is unknown.
Furthermore, the ~50x increase in the number of images resulting from a DBT exam compared to a DM exam doubles the reading time. For DBT screening in the Netherlands to be feasible from the economic and human resources point of view, the interpretation of these cases must be accelerated, to result in an average reading time comparable to that of reviewing DM exams.
The aim of this project is to make the replacement of DM with DBT in the Dutch National Breast Cancer Screening Program feasible and sustainable, by ensuring its acceptability by the various stakeholders, optimizing the acquisition and reading strategy, determining its expected impact on the national recall rate, and determining its cost-effectiveness. In addition, completion of this project will result in the creation of a DBT-based screening database available for future research.
Work Package (WP) 1 will involve the introduction of DBT in 6 of the 71 screening units in the country to screen 18,200 women for two screening rounds. This study is powered to detect a combined one-third reduction in the interval and advanced cancer rates with DBT screening as the primary endpoint. In addition, as secondary endpoints, the Dutch DBT-based screening recall rates will be determined for the first and second rounds of DBT screening. A contemporary control group of about 86,400 women screened with DM will be selected from the screening database (ScreenIT) of the national screening program. This control group will be selected to reflect the distribution of urban and rural areas as well as the mixture of mobile and fixed units of the screening units selected for the intervention group. In addition, the attendees, and the screening radiographers and radiologists will be surveyed to identify any barriers that limit acceptability of this new modality. Finally, WP1 will also involve the creation of a DBT-based screening database for further research.
In WP2, the optimal DBT reading strategy to be used in the Dutch screening program to minimize the increase in reading time with DBT, will be identified. For this, retrospective observer studies will be performed, using the images from WP1, to test eight different acquisition and reading strategies, some involving the use of cutting-edge artificial intelligence computer systems. These strategies have been shown in initial studies, many performed by the sponsor, to result in a significant reduction in reading time, with no or minimal loss in performance. Once the optimal reading strategies is identified, it will be used to interpret the entire second round of DBT screening acquired in WP1 at the screening reading units retrospectively. In this way, its actual performance and impact on reading time in the real screening environment will be determined.
Finally, in WP3, the results from the other two WPs will be used to model the entire DBT screening program and therefore predict the long-term outcomes and cost-effectiveness of this new screening program. The only method possible to estimate the impact of screening on long-term effects, such as breast cancer mortality and morbidity, as well as cost-effectiveness, is the use of modelling. Therefore, the well-validated MISCAN model will be used, with the data and results gathered, to estimate the long-term impact of DBT screening.
As a result of this project, if successful, breast cancer screening with DBT will be ready for nationwide implementation, having addressed all the country-specific questions and having optimized the DBT workflow specifically for a high-volume population-based screening program.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Diagnostic Test: Digital Breast Tomosynthesis18200 participants who will be screened with tomosynthesis instead of digital mammography. All participants will be asked to participate in the study for 2 screening rounds. The number of participants for the second round will be less, due to drop-outs. |
Who may qualify
- Ages
- 50 to 72 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who are invited to participate to the Dutch Breast Cancer Screening program in the age group 50-72 years..
Key exclusion criteria (2 listed)
- Disabled women
- Women who are wheelchair bound
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 TomosynthesisScreening with Digital Breast Tomosynthesis instead of Digital Mammography, for two screening rounds | Diagnostic test | Intervention group |
Primary outcome
The effect of DBT screening on breast cancers diagnosed at an advanced stage at screening or in between rounds of screening. (detection rate of stage II+ cancers per 1000 screens and interval cancer rate per 1000 screens)
Time frame: 5 years
The outcome will be compared to the control group (DM)
5 secondary outcomes
Attendance rate (percentage out of all women invited)
Time frame: 5 years
Recall (percentage out of all women screened)
Time frame: 5 years
Cancer detection rate for breast cancer, both invasive and in situ, overall and for cancers stage II or higher (stage II+; per 1000 screened)
Time frame: 5 years
Positive predictive value for recall (percentage of cancers detected among recalled women)
Time frame: 5 years
Interval cancer rates (breast cancer detected clinically in the first, second, or third year after a negative screening examination.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- STREAM websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The following end products will be made available for further research and verification: * Summary outcomes of the screening * Methods used during the study such as, but not limited to, data extraction algorithms, statistical analysis, and cost effectiveness
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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.
Mireille Broeders, Prof. principal investigator
Radboud University Medical Center
Ioannis Sechopoulos, Prof. principal investigator
Radboud University Medical Center
Nicolien van Ravesteyn, PhD principal investigator
Erasmus Medical Center
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 in people with Breast Cancer Screening, run by Radboud University Medical Center at 1 site in Netherlands.
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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
The effect of DBT screening on breast cancers diagnosed at an advanced stage at screening or in between rounds of screening. (detection rate of stage II+ cancers per 1000 screens and interval cancer rate per 1000 screens) (time frame: 5 years). 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 29 Jul 2025.