Artificial Intelligence in Mammography Screening in Norway
NCT ID: NCT06032390
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150000 participants
INTERVENTIONAL
2024-11-25
2033-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Intervention arm
AI assisted mammography screening interpretation
AI assisted mammography screening interpretation
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).
Control arm
Standard mammography screening interpretation (standard procedure)
Standard mammography screening interpretation
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.
Interventions
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AI assisted mammography screening interpretation
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 interpretation
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
69 Years
FEMALE
Yes
Sponsors
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Helse Vest
OTHER
Helse Midt-Norge
OTHER
Helse Nord
INDUSTRY
Norwegian Cancer Society
OTHER
Norwegian Institute of Public Health
OTHER_GOV
Responsible Party
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Principal Investigators
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Solveig Hofvind, PhD
Role: PRINCIPAL_INVESTIGATOR
Norwegian Institute of Public Health
Locations
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Cancer Registry of Norway, Norwegian Institute of Public Health
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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366405
Identifier Type: -
Identifier Source: org_study_id
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