Breast CancerAIMS NorwayNCT06032390
Artificial Intelligence in Mammography Screening in Norway
A study testing AI assisted mammography screening interpretation and Standard mammography screening interpretation in people with Breast Cancer, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
The purpose of this randomized controlled trial is to compare the number of breast cancers detected among women who had their screening mammograms interpreted by artificial intelligence (AI) in combination with one or two breast radiologists to the number of breast cancers detected after standard independent double… Read more about this study
- Who is it for?
- Ages 50 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- AI assisted mammography screening interpretation and Standard mammography screening interpretation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150,000 participants
- Where
- 1 siteNorway
- Study dates
- 25 Nov 2024to Jun 2033
- 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 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women attending the population-based mammography screening program BreastScreen Norway providing a signed, informed consent
Who cannot join
- Women attending the population-based mammography screening program BreastScreen Norway not providing a signed, informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Åsne S Holen, MSc contact
Norway1 site, 1 recruiting
- Recruiting
Cancer Registry of Norway, Norwegian Institute of Public Health
Oslo
Solveig Hofvind, PhD, +4722928828, sshh@kreftregisteret.no
About this study
Official title: Artificial Intelligence in BreastScreen Norway - a Randomized Controlled Trial
The purpose of this randomized controlled trial is to compare the number of breast cancers detected among women who had their screening mammograms interpreted by artificial intelligence (AI) in combination with one or two breast radiologists to the number of breast cancers detected after standard independent double reading in BreastScreen Norway. The aims of the study is to prove that screening interpretation with AI in combination with one or two radiologists (the intervention) is non-inferior to standard interpretation procedure.
Read the detailed description
Independent double reading with consensus is the recommended practice for breast cancer screening programs in Europe. This is a time-consuming process and more than 99% of examinations are determined to have a negative final outcome in BreastScreen Norway. However, radiologist still overlook cancers, and review-studies have shown 20-25% of screen-detected and interval cancers to be visible at prior screening mammograms. In Norway and other countries, there is also a shortage of breast radiologists.
Retrospective studies on AI in mammographic screening have shown promising results in the classification of cancer negative and cancer positive examinations. However, prospective studies are needed to elucidate questions concerning AI as a support or replacement for the radiologists in the interpretation process.
In this randomized controlled trial women attending screening and consenting to participate in the study, will be randomized (1:1 allocation) to an intervention or a control group. The screening examination will be performed as usual in both groups. The intervention in the trial is the interpretation procedure.
All examinations will be analyzed by AI. In the intervention group, examinations will be triaged according to risk of malignancy defined by an AI score. Examinations with a low AI score (1-7) will have a single reading by one radiologist and examinations with a intermediate or high AI score (8-10) will have an independent double reading by two radiologists. All examinations selected by either one or both radiologist will be discussed at consensus. Examinations with an AI raw score of >9.8 will be discussed at consensus independent of the radiologists' interpretation. The radiologists will be blinded to whether the mammograms are interpreted by one or two radiologists. AI risk scores and AI image marking of suspicious calcifications and masses are only provided to the radiologists at consensus, not during independent reading. In the control group, two independent radiologists will interpret all screening examinations according to standard procedure, independent double reading. AI results will not be available at either independent reading or consensus, only for comparison with the intervention group in final analyses.
Screen-detected cancers in the intervention and control arm will be analyzed in terms of non-inferiority.
- Conditions
- Breast Cancer
- Being tested
- AI assisted mammography screening interpretation, Standard mammography screening interpretation
- Keywords
- Breast Cancer Screening, Digital Mammography, Artificial Intelligence, Randomized Controlled Trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI assisted mammography screening interpretationOther
Screening examinations will be analyzed by the AI system (Transpara, ScreenPoint Medical, Nijmegen, The Netherlands) that assigns each examination a cancer risk score 1-10. Examinations with a score 1-7 will be single read and examinations with score 8-10 will be double read. Examinations selected by one or two readers will be discussed in a consensus meeting. Examinations with an AI score of >9.8 will be selected for the consensus meeting by default. AI risk scores and image markings are provided to the readers only in the consensus meetings. The readers will decide whether to recall the woman for further assessment in consensus (standard procedure).
Standard mammography screening interpretationOther
Screening examinations will be assessed according to standard of care: independently double read, examinations selected by one or two readers will be discussed in a consensus meeting, and the radiologists will decide whether to recall the woman for further assessment. Screening examinations will be analyzed by the AI system retrospectively but the results will not be made available to the radiologist, only used for comparison to the intervention group in results analyses.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | AI assisted mammography screening interpretation Receives: Other: AI assisted mammography screening interpretation |
| Control arm | Active comparator | Standard mammography screening interpretation (standard procedure) Receives: Other: Standard mammography screening interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screen-detected breast cancers
Number of breast cancers detected at screening per 1000 screening examinations.
Measured: 36 months from study start-up
Secondary outcomes (9)
Consensus rate
Proportion of participant discussed in consensus among all participants (%).
Measured: 24 months from study start-up
Recall rate
Proportion of women recalled for further assessment among all participants (%).
Measured: 24 months from study start-up
Interval breast cancers
Number of interval breast cancers diagnosed per 1000 screening examinations.
Measured: 60 months from study start-up
Prognostic and predictive tumor characteristics of screen-detected breast cancer
Distribution of tumor characteristics among the participants with screen-detected breast cancer.
Measured: 36 months from study start-up
Prognostic and predictive tumor characteristics of interval breast cancer
Distribution of tumor characteristics among the participants with interval breast cancer.
Measured: 60 months from study start-up
Sensitivity
Proportion of true positives among true positive and false negatives (%).
Measured: 60 months from study start-up
Specificity
Proportion of true negatives among true negatives and false positives (%).
Measured: 60 months from study start-up
Mammographic features of screen-detected breast cancer
Distribution of characteristics of tumors observed on the mammograms of participants diagnosed with screen-detected breast cancer.
Measured: 36 months from study start-up
Time spent screen-reading
Time (minutes:seconds) spent by the individual radiologists interpreting screening mammograms
Measured: 36 months from study start-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start25 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to an intervention or control arm. Intervention arm will be triaged based on AI result score.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Helse Vest, Helse Midt-Norge, Helse Nord, Norwegian Cancer Society
- Responsible party
- Sponsor
- Investigators
- Solveig Hofvind, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032390
- Sponsor's protocol ID
- 366405
- Acronym
- AIMS Norway
- Status last verified
- Jan 2026
- First submitted
- 5 Jul 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared outside the project group.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence in BreastScreen Norway - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06032390
- Acronym / sponsor ID
- AIMS Norway / 366405
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer Screening, Digital Mammography, Artificial Intelligence, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Helse Vest, Helse Midt-Norge, Helse Nord, Norwegian Cancer Society
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 13 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.
The purpose of this randomized controlled trial is to compare the number of breast cancers detected among women who had their screening mammograms interpreted by artificial intelligence (AI) in combination with one or two breast radiologists to the number of breast cancers detected after standard independent double reading in BreastScreen Norway. The aims of the study is to prove that screening interpretation with AI in combination with one or two radiologists (the intervention) is non-inferior to standard interpretation procedure.
Detailed description
Independent double reading with consensus is the recommended practice for breast cancer screening programs in Europe. This is a time-consuming process and more than 99% of examinations are determined to have a negative final outcome in BreastScreen Norway. However, radiologist still overlook cancers, and review-studies have shown 20-25% of screen-detected and interval cancers to be visible at prior screening mammograms. In Norway and other countries, there is also a shortage of breast radiologists.
Retrospective studies on AI in mammographic screening have shown promising results in the classification of cancer negative and cancer positive examinations. However, prospective studies are needed to elucidate questions concerning AI as a support or replacement for the radiologists in the interpretation process.
In this randomized controlled trial women attending screening and consenting to participate in the study, will be randomized (1:1 allocation) to an intervention or a control group. The screening examination will be performed as usual in both groups. The intervention in the trial is the interpretation procedure.
All examinations will be analyzed by AI. In the intervention group, examinations will be triaged according to risk of malignancy defined by an AI score. Examinations with a low AI score (1-7) will have a single reading by one radiologist and examinations with a intermediate or high AI score (8-10) will have an independent double reading by two radiologists. All examinations selected by either one or both radiologist will be discussed at consensus. Examinations with an AI raw score of >9.8 will be discussed at consensus independent of the radiologists' interpretation. The radiologists will be blinded to whether the mammograms are interpreted by one or two radiologists. AI risk scores and AI image marking of suspicious calcifications and masses are only provided to the radiologists at consensus, not during independent reading. In the control group, two independent radiologists will interpret all screening examinations according to standard procedure, independent double reading. AI results will not be available at either independent reading or consensus, only for comparison with the intervention group in final analyses.
Screen-detected cancers in the intervention and control arm will be analyzed in terms of non-inferiority.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be randomized to an intervention or control arm. Intervention arm will be triaged based on AI result score.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: AI assisted mammography screening interpretationAI assisted mammography screening interpretation |
| Control arm | Active comparator | Other: Standard mammography screening interpretationStandard mammography screening interpretation (standard procedure) |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women attending the population-based mammography screening program BreastScreen Norway providing a signed, informed consent
Key exclusion criteria (1 listed)
- Women attending the population-based mammography screening program BreastScreen Norway not providing a signed, informed consent
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 assisted mammography screening interpretationScreening examinations will be analyzed by the AI system (Transpara, ScreenPoint Medical, Nijmegen, The Netherlands) that assigns each examination a cancer risk score 1-10. Examinations with a score 1-7 will be single read and examinations with score 8-10 will be double read. Examinations selected by one or two readers will be discussed in a consensus meeting. Examinations with an AI score of >9.8 will be selected for the consensus meeting by default. AI risk scores and image markings are provided to the readers only in the consensus meetings. The readers will decide whether to recall the woman for further assessment in consensus (standard procedure). | Other | Intervention arm |
| Standard mammography screening interpretationScreening examinations will be assessed according to standard of care: independently double read, examinations selected by one or two readers will be discussed in a consensus meeting, and the radiologists will decide whether to recall the woman for further assessment. Screening examinations will be analyzed by the AI system retrospectively but the results will not be made available to the radiologist, only used for comparison to the intervention group in results analyses. | Other | Control arm |
Primary outcome
Screen-detected breast cancers
Time frame: 36 months from study start-up
Number of breast cancers detected at screening per 1000 screening examinations.
9 secondary outcomes
Consensus rate
Time frame: 24 months from study start-up
Recall rate
Time frame: 24 months from study start-up
Interval breast cancers
Time frame: 60 months from study start-up
Prognostic and predictive tumor characteristics of screen-detected breast cancer
Time frame: 36 months from study start-up
Prognostic and predictive tumor characteristics of interval breast cancer
Time frame: 60 months from study start-up
Sensitivity
Time frame: 60 months from study start-up
Specificity
Time frame: 60 months from study start-up
Mammographic features of screen-detected breast cancer
Time frame: 36 months from study start-up
Time spent screen-reading
Time frame: 36 months from study start-up
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 14 Jan 2026.
- Individual participant dataSharing planned: No. Data will not be shared 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.
Åsne S Holen, MSc contact
Solveig Hofvind, PhD 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 AI assisted mammography screening interpretation and Standard mammography screening interpretation in people with Breast Cancer, 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 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: looking for participants now, as of the sponsor's last update on 14 Jan 2026. 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?
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?
Contact Solveig Hofvind, PhD (22928828 ext. +47, sshh@kreftregisteret.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screen-detected breast cancers (time frame: 36 months from study start-up). 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 14 Jan 2026.