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NCT Number: NCT07075679

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

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.

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Key information

Conditions

Breast Cancer Screening Artificial Intelligence (AI) Breast Cancer Screening and Diagnosis Breast Diseases Breast Neoplasms Disease Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

45 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Olomouc

Olomouc, Czechia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • clinical signs of breast disease - indication for diagnostic mammography

Treatment and study plan

Group with AI iCAD version 3

Diagnostic Test

Reading mammograms by one radiologist with AI support

Group without AI

Diagnostic Test

Standard double reading by two radiologists without AI.

Primary outcomes

  1. Further assessment rate

    Time frame: up to 190 days after screening mammmography

    The proportion of women udergoing follow-up examinations within 0-190 days after screening mammography.

Secondary outcomes

  1. Cancer Detection Rate

    Time frame: up to 1 year after screening mammography

    The number of cancers detected per 1,000 women screened.

  2. Recall Rate

    Time frame: up to 190 days after screening mammography

    The proportion of women recalled for follow-up examinations withing 1-190 days after screening mammography.

Study contacts

Contact information is provided by the study sponsor or research team.

Lucia Veverkova, MD

CONTACT

[email protected]

+420603181913

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Registry information

Official study title

Use of Artificial Intelligence in Breast Cancer Screening: Impact of AI-Assisted Single Reading by One Radiologist on Screening Quality Indicators Compared to Standard Double Reading by Two Radiologists Without AI

Acronym: AI-BCSQ

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 20, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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