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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Therapixel
- 入组人数
- 5,000
- 试验地点
- 7
- 主要终点
- Recall rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Recall rate
时间窗: End of the inclusion period 24 months
Number of patients that are called back for further examinations divided by the total number of patient receiving a second reading.
次要结局
- Time-to-results(End of the inclusion period 24 months)
- Cancer detection rate(End of the inclusion period 24 months)
- Sensitivity and Specificity(End of the follow_up period 48 months)
- Reading time(End of the inclusion period 24 months)
- Economic impact(End of the follow_up period 48 months)