Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04778670
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-14
First Post:
2021-02-22
Brief Title:
Artificial Intelligence in Large-scale Breast Cancer Screening
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Artificial Intelligence in a Population-based Breast Cancer Screening - the Prospective Clinical Trial ScreenTrust CAD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ScreenTrustCAD
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EPM 2020-00487 | OTHER | None | None |
| K 2020-0807 | OTHER | Karolinska University Hospital | None |