Artificial Intelligence (AI), Breast Cancer Screening, Breast Cancer Screening and Diagnosis
Conditions
Keywords
breast cancer, screening, artificial intelligence
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTGroup with AI iCAD version 3
Reading mammograms by one radiologist with AI support
DIAGNOSTIC_TESTGroup without AI
Standard double reading by two radiologists without AI.
Sponsors
University Hospital Olomouc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* age 45-69, asymptomatic woman participating in breast cancer screening programme
Exclusion criteria
* clinical signs of breast disease - indication for diagnostic mammography
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Further assessment rate | up to 190 days after screening mammmography | The proportion of women udergoing follow-up examinations within 0-190 days after screening mammography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer Detection Rate | up to 1 year after screening mammography | The number of cancers detected per 1,000 women screened. |
| Recall Rate | up to 190 days after screening mammography | The proportion of women recalled for follow-up examinations withing 1-190 days after screening mammography. |
Countries
Czechia
Contacts
CONTACTLucia Veverkova, MD
Outcome results
None listed