Single radiologist with AI support versus two radiologists for screening mammograms
Use of Artificial Intelligence in Breast Cancer Screening: Impact of AI-Assisted Single Reading by One Radiologist on Screening Quality Indicators Compared to Standard Double Reading by Two Radiologists Without AI
This trial will see if one radiologist aided by AI can match the performance of the usual two-radiologist reading for screening mammograms in women aged 45–69.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8000 (estimated) |
| Ages | 45 Years to 69 Years |
| Sex | Female |
| Sponsor | University Hospital Olomouc Academic / other |
| Locations | 1 site (Olomouc) |
| Trial ID | NCT07075679 on ClinicalTrials.gov |
What this trial studies
Asymptomatic women aged 45–69 in the regional breast cancer screening program are randomized by day to have mammograms read either with an AI-assisted first reader (iCAD version 3) followed by a standard second radiologist read, or by the standard independent double reading without AI. The AI arm records the AI-assisted first read before the mandatory human second read to maintain legal double-reading requirements. Randomization assigns specific days to AI or non-AI reading to balance weekday workflow and case mix. The trial compares diagnostic outcomes such as cancer detection rate, recall rate, false positives, and workflow metrics between the two approaches.
Who should consider this trial
Good fit: Asymptomatic women aged 45–69 who are attending the breast cancer screening program and have no clinical signs of breast disease.
Not a fit: Women with clinical breast symptoms or who require diagnostic mammography, and women outside the 45–69 age range, are not eligible and would not benefit from this screening comparison.
Why it matters
Potential benefit: If successful, this approach could maintain cancer detection while reducing radiologist workload and speeding up screening workflows.
How similar studies have performed: Prior validation and pilot studies of AI in mammography have shown promising improvements in sensitivity and efficiency, but randomized comparisons of single-reader plus AI versus standard double reading are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 45-69, asymptomatic woman participating in breast cancer screening programme Exclusion Criteria: * clinical signs of breast disease - indication for diagnostic mammography
Where this trial is running
Olomouc
- University Hospital Olomouc — Olomouc, Czechia (Recruiting)
Study contacts
- Study coordinator: Lucia Veverkova, MD
- Email: lucia.veverkova@fnol.cz
- Phone: +420603181913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.