Last updated: April 11, 2024
Sponsor: Therapixel
Overall Status: Active - Recruiting
Phase
N/A
Condition
Breast Cancer
Cancer
Treatment
MammoScreen
Clinical Study ID
NCT05800132
ID-RCB 2022-A01488-35
Ages 50-74 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 theradiologist who performed the first reading of the images (L1) in the framework of theorganized breast cancer screening program
- Having expressed her willingness to participate in the study, to undergo all theprocedures and to make herself available for the expected duration of theirparticipation,
- Having completed and signed the informed consent form.
Exclusion
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 therequirements 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: poorquality of the images, non-standard mammography (projection, magnification,compression), ML/LM/SIO/XCCL or XCCM view.
Study Design
Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: MammoScreen
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
September 30, 2027
Study Description
Connect with a study center
Centre de radiologie Les Défensions
Aubagne,
FranceActive - Recruiting
Var Imagerie Medicale
Draguignan,
FranceActive - Recruiting
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper
Fréjus,
FranceActive - Recruiting
VAR IMAGERIE MEDICALE - Clinique Les Lauriers
Fréjus,
FranceActive - Recruiting
Cabinet de Radiologie du Cabot
Marseille,
FranceCompleted
Centre de Sénologie Mermoz
Marseille,
FranceActive - Recruiting
VAR IMAGERIE MEDICALE - Cabinet de Radiologie de la Gare
Saint-Raphaël,
FranceSite Not Available
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
Saint-Raphaël,
FranceActive - Recruiting
Var Imagerie Medicale
Sainte-Maxime,
FranceSite Not Available
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