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

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT05800132

Run by

Therapixel

People needed

5000

Starts

2023-06-01

Expected to finish

2027-09-01

Last updated by the study team

2024-04-12

Who can join

Age: 50 and older, up to 74. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VAR IMAGERIE MEDICALE - Clinique Les Lauriers — Fréjus, France (enrolling)
• Var Imagerie Medicale — Draguignan, France (enrolling)
• VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper — Fréjus, France (enrolling)
• Centre de radiologie Les Défensions — Aubagne, France (enrolling)
• VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon — Saint-Raphaël, France (enrolling)
• Centre de Sénologie Mermoz — Marseille, France (enrolling)
• Cabinet de Radiologie du Cabot — Marseille, France

Full record on ClinicalTrials.gov

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