Trials / Recruiting
RecruitingNCT07075679
Screening Mammography: Single Reading by One Radiologist With AI vs. Double Reading by Two Radiologists (AI-BCSQ)
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8,000 (estimated)
- Sponsor
- University Hospital Olomouc · Academic / Other
- Sex
- Female
- Age
- 45 Years – 69 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-10-06
- Primary completion
- 2028-10-05
- Completion
- 2028-10-05
- First posted
- 2025-07-20
- Last updated
- 2026-04-02
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT07075679. Inclusion in this directory is not an endorsement.