Artificial Intelligence in Mammography Screening in Norway
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-69
SponsorNorwegian Institute of Public Health
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women attending the population-based mammography screening program BreastScreen Norway providing a signed, informed consent
Disqualifiers
Women attending the population-based mammography screening program BreastScreen Norway not providing a signed, informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
AI assisted mammography screening interpretation
Other interventionScreening 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
Other interventionScreening 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.
Treatment groups
150,000 Participants
are divided into 2 treatment groupsGroup A: Intervention armExperimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Screen-detected breast cancers
Number of breast cancers detected at screening per 1000 screening examinations.
Time frame
36 months from study start-upSecondary outcomes
1
Consensus rate
Proportion of participant discussed in consensus among all participants (%).
Time frame
24 months from study start-up2
Recall rate
Proportion of women recalled for further assessment among all participants (%).
Time frame
24 months from study start-up3
Interval breast cancers
Number of interval breast cancers diagnosed per 1000 screening examinations.
Time frame
60 months from study start-up4
Prognostic and predictive tumor characteristics of screen-detected breast cancer
Distribution of tumor characteristics among the participants with screen-detected breast cancer.
Time frame
36 months from study start-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Norwegian Institute of Public Health
Lead sponsor
Helse Vest
Collaborator
Helse Midt-Norge
Collaborator
Helse Nord
Collaborator
Norwegian Cancer Society
Collaborator
Source ClinicalTrials.gov