Artificial Intelligence in Mammography Screening in Norway
Artificial Intelligence in BreastScreen Norway - a Randomized Controlled Trial
Norwegian Institute of Public Health
150,000 participants
Nov 25, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria1
- Women attending the population-based mammography screening program BreastScreen Norway providing a signed, informed consent
Exclusion Criteria1
- Women attending the population-based mammography screening program BreastScreen Norway not providing a signed, informed consent
Interventions
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).
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06032390