Artificial Intelligence in a Population-based Breast Cancer Screening - the Prospective Clinical Trial ScreenTrust CAD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasm Female
- Sponsor
- Karolinska University Hospital
- Enrollment
- 55579
- Locations
- 1
- Primary Endpoint
- Incident breast cancer
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a prospective clinical trial following a paired screen-positive design, with the aims to assess the performance of an artificial intelligence (AI) computer-aided detection (CAD) algorithm as an independent reader, in addition to two radiologists, of screening mammograms in a true screening population. Since all decisions by individual readers will be recorded, it is possible to determine what the outcome would have been had one or two of the readers not been allowed to assess images, and to determine what the outcome would have been had the recall decision been performed by consensus decision (actual) compared to single reader arbitration of discordant cases.
Investigators
Fredrik Strand
Registrar (biträdande överläkare)
Karolinska University Hospital
Eligibility Criteria
Inclusion Criteria
- •Participants in regular population-based breast cancer screening at Capio St Göran Hospital
Exclusion Criteria
- •Incomplete exam (complete exam: mediolateral oblique and craniocaudal images of Left and Right breast)
- •Breast implant
- •Complete mastectomy (excluded from screening positive group)
- •Participant in surveillance program for prior breast cancer
Outcomes
Primary Outcomes
Incident breast cancer
Time Frame: Within 23 months after screening
Breast cancer diagnosis by pathologist
Secondary Outcomes
- Consensus recall(At screening)
- Tissue sampling(At screening)
- Process failure(At screening)
- Reader flagging(At screening)