A randomized prospective study comparing the evaluation of mammography images in a breast cancer screening programme by a single radiologist with AI support versus standard double reading by two radiologists without AI support.
In the intervention group, the first reading of the screening mammogram will be performed by one radiologist with AI support. After this AI-assisted first reading is completed and recorded for the study, a standard second reading will be carried out by another radiologist. This ensures that the legal requirement for double reading in the breast cancer screening program is maintained. In the control group, mammograms will be evaluated according to the current standard practice - that is, independently by two radiologists without AI support. Participants will be divided to the two groups based on a randomization scheme that determines specific days for evaluation with AI (Group 1) and without AI (Group 2). The randomization ensures equal distribution of weekdays between the two groups to minimize bias due to variability in daily workflow, diagnostic/screening ratios, or other operational factors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
8,000
Reading mammograms by one radiologist with AI support
Standard double reading by two radiologists without AI.
University Hospital Olomouc
Olomouc, Czechia
RECRUITINGFurther assessment rate
The proportion of women udergoing follow-up examinations within 0-190 days after screening mammography.
Time frame: up to 190 days after screening mammmography
Cancer Detection Rate
The number of cancers detected per 1,000 women screened.
Time frame: up to 1 year after screening mammography
Recall Rate
The proportion of women recalled for follow-up examinations withing 1-190 days after screening mammography.
Time frame: up to 190 days after screening mammography
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