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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 50
Maximum Age: 74
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
France
Centre de radiologie Les Défensions
RECRUITING
Aubagne
Var Imagerie Medicale
RECRUITING
Draguignan
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper
RECRUITING
Fréjus
VAR IMAGERIE MEDICALE - Clinique Les Lauriers
RECRUITING
Fréjus
Cabinet de Radiologie du Cabot
COMPLETED
Marseille
Centre de Sénologie Mermoz
RECRUITING
Marseille
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
RECRUITING
Saint-raphaël
Contact Information
Primary
Brigitte Seradour
brigitteseradour@hotmail.fr
06 09 88 38 64
Backup
Patrice Heid
p.heid@depistage-cancerssud.org
06 09 07 83 67
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 5000
Treatments
No_intervention: L2 - Standard second read
Interpretation of mammograms done by a radiologist accredited to do second reading in France.
Experimental: L2-AI - AI-assisted second read
Interpretation of mammograms done by the AI-based device. Mammograms deemed suspicious by the AI (i.e., receiving an AI global score higher than a defined threshold) will be interpreted by a radiologist accredited to do second reading in France. Mammograms assessed as negative or low suspicious by the AI won't be further interpreted by a radiologist.
Related Therapeutic Areas
Sponsors
Leads: Therapixel

This content was sourced from clinicaltrials.gov