Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MammoScreen.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 50 years — 74 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
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), * Second reading assisted by the AI (L2-AI experimental arm): mammograms will be read by the AI first and only if deemed suspicious, a radiologist accredited to do second reading in France will review them.
The most pejorative assessment among the two arms is used as the final decision: if both arms consider the mammogram as negative, the participant won't be recalled, if one arm consider the mammogram as positive, the participant will be called back for further examinations.
Clinical performances and economical impacts of both scenarii will be compared.
Interventions
- Device MammoScreen
Diagnostic reading aid for breast cancer screening
Primary outcome measures
- Recall rate [Time frame: End of the inclusion period 24 months]
Secondary outcome measures (5)
- Cancer detection rate [Time frame: End of the inclusion period 24 months]
- Sensitivity and Specificity [Time frame: End of the follow_up period 48 months]
- Economic impact [Time frame: End of the follow_up period 48 months]
- Time-to-results [Time frame: End of the inclusion period 24 months]
- Reading time [Time frame: End of the inclusion period 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 7 centers
- Centre de radiologie Les Défensions — Aubagne
- Var Imagerie Medicale — Draguignan
- VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper — Fréjus
- VAR IMAGERIE MEDICALE - Clinique Les Lauriers — Fréjus
- Cabinet de Radiologie du Cabot — Marseille
- Centre de Sénologie Mermoz — Marseille
- VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon — Saint-Raphaël
Identifiers
NCT: NCT05800132 · ID-RCB 2022-A01488-35