Clinical trial Recruiting at 1 site Interventional Ages 45 to 69 Women only

Single radiologist with AI support versus two radiologists for screening mammograms

Official title: 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

Run by University Hospital Olomouc · NCT07075679 · Data updated 2026-11-12

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

Study typeInterventional
Ages45 Years to 69 Years
SexWomen only
Enrollment8000 (estimated)
SponsorUniversity Hospital Olomouc
Academic / other
Locations1 site (Olomouc)
StatusRecruiting
StartedOctober 6, 2025
Main results expectedOctober 5, 2028
Study endsOctober 5, 2028
Registry record updatedApril 2, 2026
Trial IDNCT07075679 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Asymptomatic women aged 45–69 who are attending the breast cancer screening program and have no clinical signs of breast disease.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University Hospital Olomouc
    Olomouc, Czechia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.