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RECRUITING
NCT05800132
NA

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

Sponsor: Therapixel

View on ClinicalTrials.gov

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

DEVICE

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