Artificial Intelligence in Large-scale Breast Cancer Screening

Not Applicable

Active, not recruiting

• Conditions: Breast Neoplasm Female
• Interventions: Diagnostic Test: AI CAD; Diagnostic Test: Radiologist reading

• Registration Number: NCT04778670
• Lead Sponsor: Karolinska University Hospital

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

Not available

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-03
• Study Start: 2021-04-01
• Primary Completion: 2022-06-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-14
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 55579

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AI CAD combination	AI CAD	AI CAD combination in the primary end-point means the combination of the flagging decision of the first reader and AI CAD; in the secondary end-points it means any combination of AI alone, or AI in combination with first, second and both readers.
AI CAD combination	Radiologist reading	AI CAD combination in the primary end-point means the combination of the flagging decision of the first reader and AI CAD; in the secondary end-points it means any combination of AI alone, or AI in combination with first, second and both readers.
Standard of Care	Radiologist reading	Standard of Care means all examinations will receive a flagging decision by: first reader and second reader radiologist as usual. However, in this paired design all participants will belong to both arms.

Primary Outcome Measures

Name	Time	Method
Incident breast cancer	Within 23 months after screening	Breast cancer diagnosis by pathologist

Secondary Outcome Measures

Name	Time	Method
Consensus recall	At screening	A decision by the consensus discussion to recall the woman for further work-up
Tissue sampling	At screening	Biopsy or fine needle aspiration performed
Process failure	At screening	Failure of the AI CAD software to generate AI scores
Reader flagging	At screening	Radiologist or AICAD assessing the mammograms as suspicious or not suspicious for malignancy

Trial Locations

Locations (1)

Capio St Göran Hospital; 🇸🇪 Stockholm, Sweden