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Artificial Intelligence in Mammography Screening in Norway
Sponsor: Norwegian Institute of Public Health
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.
Official title: Artificial Intelligence in BreastScreen Norway - a Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
50 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
150000
Start Date
2024-11-25
Completion Date
2033-06
Last Updated
2026-01-14
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Cancer Registry of Norway, Norwegian Institute of Public Health
Oslo, Norway