Status:
RECRUITING
Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
Lead Sponsor:
Therapixel
Conditions:
Breast Cancer
Eligibility:
FEMALE
50-74 years
Phase:
NA
Brief 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...
Detailed Description
All mammograms eligible for a second reading, and included in the study, go through 2 arms: * Conventional second reading by a radiologist accredited to do second reading in France (L2 control arm), ...
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT05800132
Start Date
June 1 2023
End Date
September 1 2027
Last Update
April 12 2024
Active Locations (7)
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1
Centre de radiologie Les Défensions
Aubagne, France
2
Var Imagerie Medicale
Draguignan, France
3
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper
Fréjus, France
4
VAR IMAGERIE MEDICALE - Clinique Les Lauriers
Fréjus, France