Artificial Intelligence in Large-scale Breast Cancer Screening

Breast Neoplasm Female Clinical Trial

— ScreenTrustCAD  

Official title:

Artificial Intelligence in a Population-based Breast Cancer Screening - the Prospective Clinical Trial ScreenTrust CAD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04778670
• Other study ID #: STGKS001
• Secondary ID: EPM 2020-00487K
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55579
• Est. completion date: December 2024
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms

Intervention

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.
• 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)

Locations

Country	Name	City	State
Sweden	Capio St Göran Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska University Hospital	Capio Sankt Görans Hospital, Karolinska Institutet, Lunit Inc.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident breast cancer	Breast cancer diagnosis by pathologist	At Screening
Primary	Incident breast cancer	Breast cancer diagnosis by pathologist	Within 12 months after screening
Primary	Incident breast cancer	Breast cancer diagnosis by pathologist	Within 23 months after screening
Secondary	Reader flagging	Radiologist or AICAD assessing the mammograms as suspicious or not suspicious for malignancy	At screening
Secondary	Consensus recall	A decision by the consensus discussion to recall the woman for further work-up	At screening
Secondary	Tissue sampling	Biopsy or fine needle aspiration performed	At screening
Secondary	Process failure	Failure of the AI CAD software to generate AI scores	At screening