RecruitingNot ApplicableNCT05800132

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

Évaluation de la Performance Diagnostique du dépistage du Cancer du Sein, Pour Une Seconde Lecture Des clichés de Mammographie assistée du Dispositif médical à Base d'Intelligence Artificielle MammoScreen

Sponsor

Therapixel

Enrollment

5,000 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 50 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether AI-assisted second reading of mammograms — after a radiologist's first review — improves the detection of breast cancer compared to the standard two-radiologist review process in France. **You may be eligible if...** - You are part of France's organized breast cancer screening program - Your mammogram has 4 standard views meeting quality standards - Your first radiologist read your mammogram as normal or showing only benign findings - You have signed the informed consent form **You may NOT be eligible if...** - You have breast implants - You have symptoms of breast cancer - You have had prior breast surgery (reduction or benign lesion removal) - You are pregnant or breastfeeding - You have cognitive or psychiatric conditions affecting your ability to consent - Your mammogram images are poor quality or non-standard Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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