Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

50 years - 74 years

Sex eligible

Female

Healthy volunteers

Accepted

Participants

3500 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The goal of this clinical trial is to compare, for the second reading of screening mammograms, the standard of care with an AI assisted scenario.

The main questions it aims to answer are:

• will the experimental pathway be non-inferior to the standard pathway?
• will the experimental pathway be economically superior to the standard pathway?

Participants will receive screening mammograms, as part of the breast cancer screening program. Researchers will compare the interpretation made by the second reader in the standard pathway with the AI assisted interpretation made by a different reader in the experimental pathway.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Affiliated to the French social security system
• Whose mammograms meet the following characteristics: 4 (2 per breast, CC and MLO) meeting local regulatory standards and with correct DICOM metadata,
• Whose mammograms have been determined to be normal or to have benign lesions by the radiologist who performed the first reading of the images (L1) in the framework of the organized breast cancer screening program
• Having expressed her willingness to participate in the study, to undergo all the procedures and to make herself available for the expected duration of their participation,
• Having completed and signed the informed consent form.

Exclusion Criteria:

• Woman with breast implants,
• With clinical symptoms of breast cancer,
• With a history of breast surgery (breast reduction or surgery for benign lesion),
• Pregnant or breastfeeding,
• With medical conditions that may interfere with her ability to understand the requirements of the protocol or give informed consent,
• Deprived of liberty by judicial or administrative order,
• Participant whose mammogram images have at least one of the following defects: poor quality of the images, non-standard mammography (projection, magnification, compression), ML/LM/SIO/XCCL or XCCM view.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (7)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

7 locations

Study team and timeline

Lead sponsor

Therapixel

Study start

Jun 1, 2023 Actual

Primary completion

Sep 1, 2025 Actual

Study completion

Sep 1, 2025 Actual

First posted

Apr 5, 2023 Actual

Last updated

Nov 9, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.