Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
IMA-L2
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
1 other identifier
interventional
5,000
1 country
7
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jun 2023
Typical duration for not_applicable breast-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
ExpectedApril 12, 2024
April 1, 2024
2.2 years
March 23, 2023
April 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recall rate
Number of patients that are called back for further examinations divided by the total number of patient receiving a second reading.
End of the inclusion period 24 months
Secondary Outcomes (5)
Cancer detection rate
End of the inclusion period 24 months
Sensitivity and Specificity
End of the follow_up period 48 months
Economic impact
End of the follow_up period 48 months
Time-to-results
End of the inclusion period 24 months
Reading time
End of the inclusion period 24 months
Study Arms (2)
L2 - Standard second read
NO INTERVENTIONInterpretation of mammograms done by a radiologist accredited to do second reading in France.
L2-AI - AI-assisted second read
EXPERIMENTALInterpretation 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Therapixellead
Study Sites (7)
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
Cabinet de Radiologie du Cabot
Marseille, France
Centre de Sénologie Mermoz
Marseille, France
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
Saint-Raphaël, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brigitte Seradour
Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Région Sud PACA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2023
First Posted
April 5, 2023
Study Start
June 1, 2023
Primary Completion
August 1, 2025
Study Completion (Estimated)
September 1, 2027
Last Updated
April 12, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share