Artificial Intelligence in Large-scale Breast Cancer Screening (ScreenTrustCAD)

Karolinska University Hospital

Status: Active, not recruiting

Conditions: Breast Neoplasm Female

Treatments: Diagnostic Test: AI CAD; Diagnostic Test: Radiologist reading

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04778670

K 2020-0807 (Other Identifier)

STGKS001

EPM 2020-00487 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 55,579 patients

Sex: Female

Ages: 40 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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55,579 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Radiologist reading

AI CAD combination

Experimental group

Description:

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.

Treatment:

Diagnostic Test: AI CAD

Diagnostic Test: Radiologist reading