Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
About this study
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.
- Condition
- Breast Cancer
- Tested
- MammoScreen
- Sponsor
- Therapixel
Who can join
- Age
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
Inclusion 9
- Minimum age: 50 years
- Maximum age: 74 years
- Eligible sex: Female
- Study condition: Breast Cancer
- 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 7
- 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.
Where
7 sites, 6 recruiting
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
Centre de Sénologie Mermoz
Marseille, France
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
Saint-Raphaël, France
and 1 more site on ClinicalTrials.gov
Contact
-
Brigitte Seradour
06 09 88 38 64 brigitteseradour@hotmail.fr
-
Patrice Heid
06 09 07 83 67 p.heid@depistage-cancerssud.org
Potential match only. Final eligibility is determined by the study team.