Recruiting
Screening Mammography: Single Reading by One Radiologist With AI vs. Double Reading by Two Radiologists (AI-BCSQ)
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.
ClinicalTrials.gov IDNCT07075679
PhaseNA
Enrollment8000
SponsorUniversity Hospital Olomouc
Age45 Years – 69 Years
SexFEMALE
Conditions studied
Breast Cancer Screening, Artificial Intelligence (AI), Breast Cancer Screening and Diagnosis
About this study
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.
Interventions
- Diagnostic Test: Group with AI iCAD version 3 — Reading mammograms by one radiologist with AI support
- Diagnostic Test: Group without AI — Standard double reading by two radiologists without AI.
Primary outcomes
- Further assessment rate (up to 190 days after screening mammmography)
Eligibility information
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 locations
- University Hospital Olomouc, Olomouc, Czechia
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-21.