Actively Recruiting
Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
Led by Therapixel · Updated on 2024-04-12
5000
Participants Needed
7
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged between 50 and 74 years
- Affiliated with the French social security system
- Mammograms must include 4 images (2 per breast, CC and MLO) meeting local regulatory standards with correct DICOM metadata
- Mammograms previously read as normal or benign lesions by the first radiologist in the screening program
- Willing to participate, undergo all procedures, and be available for the study duration
- Completed and signed informed consent form
You will not qualify if you...
- Women with breast implants
- Women showing clinical symptoms of breast cancer
- History of breast surgery such as breast reduction or surgery for benign lesions
- Pregnant or breastfeeding women
- Medical conditions preventing understanding of the study or giving informed consent
- Women deprived of liberty by judicial or administrative order
- Mammogram images with defects such as poor quality, non-standard mammography types, or specific unsupported views (ML/LM/SIO/XCCL or XCCM)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Centre de radiologie Les Défensions
Aubagne, France
Actively Recruiting
2
Var Imagerie Medicale
Draguignan, France
Actively Recruiting
3
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper
Fréjus, France
Actively Recruiting
4
VAR IMAGERIE MEDICALE - Clinique Les Lauriers
Fréjus, France
Actively Recruiting
5
Cabinet de Radiologie du Cabot
Marseille, France
Completed
6
Centre de Sénologie Mermoz
Marseille, France
Actively Recruiting
7
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
Saint-Raphaël, France
Actively Recruiting
Research Team
B
Brigitte Seradour
CONTACT
P
Patrice Heid
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
SCREENING
Number of Arms
2
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