Screening Mammography: Single Reading by One Radiologist With AI vs. Double Reading by Two Radiologists (AI-BCSQ)

University Hospital Olomouc

Status: Not yet enrolling

Conditions: Breast Cancer Screening and Diagnosis; Breast Cancer Screening; Artificial Intelligence (AI)

Treatments: Diagnostic Test: Group with AI iCAD version 3; Diagnostic Test: Group without AI

Study type: Interventional

Funder types: Other

Identifiers

NCT07075679

03062025

IGA_LF_2024_022 (Other Grant/Funding Number)

Details and patient eligibility

About

A randomized prospective study comparing the evaluation of mammography images in a breast cancer screening programme by a single radiologist with AI support versus standard double reading by two radiologists without AI support.

Full description

In the intervention group, the first reading of the screening mammogram will be performed by one radiologist with AI support. After this AI-assisted first reading is completed and recorded for the study, a standard second reading will be carried out by another radiologist. This ensures that the legal requirement for double reading in the breast cancer screening program is maintained.

In the control group, mammograms will be evaluated according to the current standard practice - that is, independently by two radiologists without AI support.

Participants will be divided to the two groups based on a randomization scheme that determines specific days for evaluation with AI (Group 1) and without AI (Group 2). The randomization ensures equal distribution of weekdays between the two groups to minimize bias due to variability in daily workflow, diagnostic/screening ratios, or other operational factors.

Enrollment: 8,000 estimated patients

Sex: Female

Ages: 45 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 45-69, asymptomatic woman participating in breast cancer screening programme

Exclusion criteria

• clinical signs of breast disease - indication for diagnostic mammography

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8,000 participants in 2 patient groups

Group with AI

Experimental group

Description:

Asymptomatic women aged 45-69 participating in breast cancer screening programme, reading of mammograms by one radiologist with AI support.

Treatment:

Diagnostic Test: Group with AI iCAD version 3

Group without AI

Other group

Description:

Asymptomatic women aged 45-69 participating in breast cancer screening programme, reading of mammograms by two radiologists without AI (current practice).

Treatment:

Diagnostic Test: Group without AI