Breast Cancer Screening Programme: AI-assisted Single Reading by One Radiologist vs. Standard Double Reading by Two Radiologist

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer Screening; Artificial Intelligence (AI); Breast Cancer Screening and Diagnosis

• Registration Number: NCT07075679
• Lead Sponsor: University Hospital Olomouc

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Study Start: 2025-08-04
• Primary Completion: 2028-08-03
• Study Completion: 2028-08-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 8000

Inclusion Criteria

• age 45-69, asymptomatic woman participating in breast cancer screening programme

Exclusion Criteria

• clinical signs of breast disease - indication for diagnostic mammography

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Cancer Detection Rate	up to 1 year after screening mammography	The number of cancers detected per 1,000 women screened.