Multinational Clinical Trial of Real-time Artificial Intelligence System (CadAI-B) for Breast Ultrasound: Prospective Clinical Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Lesion and Per-patient Diagnostic Performance
研究概览
简要总结
The CadAI-B (Computer Aided Design Artificial Intelligence-Breast) system is a real-time AI diagnostic tool for breast ultrasound. It integrates with ultrasound devices to detect suspicious lesions, providing size, BI-RADS, and malignancy probability. After installation and user training, the system displays real-time breast conditions and automatically analyzes lesions when a freeze frame is set, showing results in seconds. This study will assess CadAI-B's accuracy and reliability by comparing its findings with biopsy results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20 years or older
- •Individuals scheduled to undergo breast ultrasound for diagnostic evaluation
- •Patients whose Ground Truth can be determined through biopsy, surgery, or follow-up
排除标准
- •Images containing artifacts that may affect the interpretation
- •Presence of breast implants
- •Significant breast trauma or mastitis at the time of the breast ultrasound that could cause distortion in image interpretation
- •History of surgery or chemotherapy
结局指标
主要结局
Lesion and Per-patient Diagnostic Performance
时间窗: At the end of the trial, up to 6 months
AUC (Area Under the Curve), Sensitivity, Specificity
次要结局
- Lesion and Per-patient Detection Performance(At the end of the trial, up to 6 months)
研究者
JeeYeon Lee
Associate professor
Kyungpook National University Chilgok Hospital