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Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
Sponsor: Therapixel
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
50 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
5000
Start Date
2023-06-01
Completion Date
2027-09
Last Updated
2024-04-12
Healthy Volunteers
Yes
Conditions
Interventions
MammoScreen
Diagnostic reading aid for breast cancer screening
Locations (7)
Centre de radiologie Les Défensions
Aubagne, France
Var Imagerie Medicale
Draguignan, France
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper
Fréjus, France
VAR IMAGERIE MEDICALE - Clinique Les Lauriers
Fréjus, France
Cabinet de Radiologie du Cabot
Marseille, France
Centre de Sénologie Mermoz
Marseille, France
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
Saint-Raphaël, France