Trials / Unknown
UnknownNCT04778670
Artificial Intelligence in Large-scale Breast Cancer Screening
Artificial Intelligence in a Population-based Breast Cancer Screening - the Prospective Clinical Trial ScreenTrust CAD
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55,579 (actual)
- Sponsor
- Karolinska University Hospital · Academic / Other
- Sex
- Female
- Age
- 40 Years – 74 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | AI CAD | The Lunit INSIGHT MMG will be used as the AI CAD in our study. Initially, version 1.6.1.1 will be installed. The software version will be continuously updated with subsequent software releases, after confirming in a historic calibration dataset that the performance is improved. The operating point will be set based on a historic calibration dataset to attain a joint sensitivity of breast cancer detection of AI and first reader which is 2% higher than for first and second reader. |
| DIAGNOSTIC_TEST | Radiologist reading | Standard of care, each radiologist will assess the mammography examination, making a binary flagging decision (flag the examination to continue to consensus discussion, or not) |
Timeline
- Start date
- 2021-04-01
- Primary completion
- 2022-06-09
- Completion
- 2024-12-01
- First posted
- 2021-03-03
- Last updated
- 2023-03-14
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT04778670. Inclusion in this directory is not an endorsement.