Artificial IntelligenceAIM-RÖNCT06187350
The Use of AI to Safely Reduce the Workload in Breast Cancer Screening With Mammography in Region Östergötland
An observational study of Artificial Intelligence and Breast Diseases, run by Ostergotland County Council, Sweden at 1 site in Sweden.
Trial summary
The overall aim of the project is to investigate how artificial intelligence (AI) can be used to streamline and at the same time increase diagnostic safety in breast cancer screening with mammography. AI has been shown in a number of studies to have great potential for both increasing diagnostic certainty (e.g. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women only
- Conditions the study is for
- Artificial Intelligence, Breast Diseases, Neoplasms
- What is being tested?
- AI cancer detection system
- Type of treatment
- Medical device
- How many people
- 60,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2023to 20 Mar 2025
- How long will I take part?
- 4 Years
- Phase
- Observational
- 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
Study population: Women eligible for population-based mammography screening
Who may be able to join
- Women participating in the regular Breast Cancer Screening Program in Region Östergötland
Who cannot join
- Women with breast implants or other foreign implants in the mammogram Women with symptoms or signs of suspected breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Artificial Intelligence (AI) to Safely Reduce the Workload in Breast Cancer Screening With Mammography in Region Östergötland
The overall aim of the project is to investigate how artificial intelligence (AI) can be used to streamline and at the same time increase diagnostic safety in breast cancer screening with mammography. AI has been shown in a number of studies to have great potential for both increasing diagnostic certainty (e.g. reduced occurrence of interval cancers) and at the same time reducing the workload for doctors. However, much research remains to clinically validate these new tools and to increase the understanding of how they affect the work of doctors. The specific goal of the project is to investigate whether the implementation of AI in breast cancer screening in Östergötland, Sweden, can increase the sensitivity (the mammography examination's ability to find breast cancer) and the specificity (that is, the right case is selected for further investigation: a minimum of healthy women are recalled but so many breast cancer cases that are possible are selected for further investigation) and at the same time make screening more efficient through reduced workload. AI will be implemented in the clinical routine and performance metrics such as cancer detection rate etc will be closely monitored. The study do not assign specific interventions to the study participants.
Read the detailed description
The overall aim of the project is to study whether the use of artificial intelligence can improve breast cancer screening with mammography. AI will be implemented in the clinical routine and performance metrics such as cancer detection rate etc will be closely monitored. The study do not assign specific interventions to the study participants. The specific objective is to investigate whether the use of AI leads to increased diagnostic safety in mammography in Östergötland (measured as a reduced incidence of interval cancer) and at the same time leads to a reduced workload for the breast radiologists. Furthermore, the intention is to investigate how the use of AI affects the breast radiologists´ work in terms of reading time per examination and whether the radiologists' specificity and sensitivity are affected when they have access to the decision support based on AI during the review compared to if they do not have this support.
The hypotheses are that:
- The use of AI in breast cancer screening in Östergötland Sweden improves the diagnostic quality. As a result, more breast cancer cases are detected early and the incidence of interval cancer decreases.
- The reduced workload for the radiologists in Östergötland that could be demonstrated through the data collected in Östergötland 2021-2022 [NCT05048095 - Artificial Intelligence in Breast Cancer Screening in Region Östergötland Linkoping (AI-ROL)] can also be demonstrated in a large-scale prospective study.
- Through the use of an AI-based decision support, not only can double review be eliminated for those cases where the AI assesses the cancer risk as low, but also each examination can be reviewed more quickly while maintaining or improving diagnostic certainty.
- It is the least experienced radiologists who are most helped by the decision support, both for increased diagnostic certainty and increased efficiency.
- Conditions
- Artificial Intelligence, Breast Diseases, Neoplasms, Breast Neoplasms
- Being tested
- AI cancer detection system
- Medical subject headings
- Breast Diseases, Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI cancer detection systemDevice
Also called Screenpoint Transpara
The AI system Transpara (Screenpoint Medical, The Netherlands) will be implemented for triaging two-image mammography examinations based on the probability of malignancy. Transpara assigns a score from 1 to 10 to each examination, indicating the risk of malignancy. A score between 1 and 7 indicates a low risk of cancer, 8-9 indicates an intermediate and 10 an elevated risk of cancer. Examinations with an AI score between 1 and 7 will be reviewed by only one radiologist, while examinations with an AI score > 7 will be double-reviewed as normal.
| Study group | Role | What they receive |
|---|---|---|
| Screened women in Region Östergötland, Sweden | All screened women in Region Östergötland, Sweden. Receives: Device: AI cancer detection system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Detection rate
Proportion of women diagnosed with breast cancer among those recalled after consensus
Measured: 4 Years
Positive predictive value of Transpara® scores
Proportion of breast cancers diagnosed among women with a given AI score
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Aug 2023
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60,000 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Håkan Gustafsson, Ostergotland County Council, Sweden
- Investigators
- Håkan Gustafsson, Ph.D., Principal investigator, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187350
- Sponsor's protocol ID
- AIM-RÖ
- Acronym
- AIM-RÖ
- Status last verified
- Jun 2025
- First submitted
- 10 Jul 2023
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data (IPD) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Artificial Intelligence (AI) to Safely Reduce the Workload in Breast Cancer Screening With Mammography in Region Östergötland
- ClinicalTrials.gov ID
- NCT06187350
- Acronym / sponsor ID
- AIM-RÖ / AIM-RÖ
- Conditions
- Artificial Intelligence, Breast Diseases, Neoplasms, Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60,000 participants (actual)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 2 Jan 2024 (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 overall aim of the project is to investigate how artificial intelligence (AI) can be used to streamline and at the same time increase diagnostic safety in breast cancer screening with mammography. AI has been shown in a number of studies to have great potential for both increasing diagnostic certainty (e.g. reduced occurrence of interval cancers) and at the same time reducing the workload for doctors. However, much research remains to clinically validate these new tools and to increase the understanding of how they affect the work of doctors. The specific goal of the project is to investigate whether the implementation of AI in breast cancer screening in Östergötland, Sweden, can increase the sensitivity (the mammography examination's ability to find breast cancer) and the specificity (that is, the right case is selected for further investigation: a minimum of healthy women are recalled but so many breast cancer cases that are possible are selected for further investigation) and at the same time make screening more efficient through reduced workload. AI will be implemented in the clinical routine and performance metrics such as cancer detection rate etc will be closely monitored. The study do not assign specific interventions to the study participants.
Detailed description
The overall aim of the project is to study whether the use of artificial intelligence can improve breast cancer screening with mammography. AI will be implemented in the clinical routine and performance metrics such as cancer detection rate etc will be closely monitored. The study do not assign specific interventions to the study participants. The specific objective is to investigate whether the use of AI leads to increased diagnostic safety in mammography in Östergötland (measured as a reduced incidence of interval cancer) and at the same time leads to a reduced workload for the breast radiologists. Furthermore, the intention is to investigate how the use of AI affects the breast radiologists´ work in terms of reading time per examination and whether the radiologists' specificity and sensitivity are affected when they have access to the decision support based on AI during the review compared to if they do not have this support.
The hypotheses are that:
- The use of AI in breast cancer screening in Östergötland Sweden improves the diagnostic quality. As a result, more breast cancer cases are detected early and the incidence of interval cancer decreases.
- The reduced workload for the radiologists in Östergötland that could be demonstrated through the data collected in Östergötland 2021-2022 [NCT05048095 - Artificial Intelligence in Breast Cancer Screening in Region Östergötland Linkoping (AI-ROL)] can also be demonstrated in a large-scale prospective study.
- Through the use of an AI-based decision support, not only can double review be eliminated for those cases where the AI assesses the cancer risk as low, but also each examination can be reviewed more quickly while maintaining or improving diagnostic certainty.
- It is the least experienced radiologists who are most helped by the decision support, both for increased diagnostic certainty and increased efficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screened women in Region Östergötland, Sweden | – | Device: AI cancer detection systemAll screened women in Region Östergötland, Sweden. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women eligible for population-based mammography screening
Key inclusion criteria (1 listed)
- Women participating in the regular Breast Cancer Screening Program in Region Östergötland
Key exclusion criteria (1 listed)
- Women with breast implants or other foreign implants in the mammogram Women with symptoms or signs of suspected breast cancer
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 |
|---|---|---|
| AI cancer detection systemAlso: Screenpoint TransparaThe AI system Transpara (Screenpoint Medical, The Netherlands) will be implemented for triaging two-image mammography examinations based on the probability of malignancy. Transpara assigns a score from 1 to 10 to each examination, indicating the risk of malignancy. A score between 1 and 7 indicates a low risk of cancer, 8-9 indicates an intermediate and 10 an elevated risk of cancer. Examinations with an AI score between 1 and 7 will be reviewed by only one radiologist, while examinations with an AI score > 7 will be double-reviewed as normal. | Device | Screened women in Region Östergötland, Sweden |
Primary outcome
Cancer Detection rate
Time frame: 4 Years
Proportion of women diagnosed with breast cancer among those recalled after consensus
Positive predictive value of Transpara® scores
Time frame: 4 Years
Proportion of breast cancers diagnosed among women with a given AI score
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 6 Jun 2025.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared.
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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.
Håkan Gustafsson, Ph.D. principal investigator
Region Östergötland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Artificial Intelligence and Breast Diseases, run by Ostergotland County Council, Sweden 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 1 inclusion and 1 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 6 Jun 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 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?
Cancer Detection rate (time frame: 4 Years). The study lists 2 primary outcomes in all. 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 6 Jun 2025.