Development and Validation of an Artificial Intelligence System for Anatomic Site Recognition and Lesion Detection Based on Electronic Nasopharyngolaryngoscopic Images: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- performance of lesion detection
研究概览
简要总结
An artificial intelligence-assisted system is trained and validated by collecting nasopharyngolaryngoscopy images from patients.
详细描述
To address the clinical pain points of traditional nasopharyngolaryngoscopy, such as incomplete visualization, inaccurate identification, and unclear imaging, this study will retrospectively collect nasopharyngolaryngoscopy images and baseline information (including gender and age) of patients who underwent nasopharyngolaryngoscopy at participating centers for model training and validation. Deep learning algorithms will be applied to construct the model. The final clinical performance evaluation of the model will be conducted using an independent, prospectively collected test cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Underwent standard electronic nasopharyngolaryngoscopy;
- •Patients who underwent biopsy sampling have a clear pathological diagnosis;
- •Signed a written informed consent form.
排除标准
- •Image quality is substandard with severe motion artifacts;
- •Lesion images are unclear and incomplete.
结局指标
主要结局
performance of lesion detection
时间窗: Within 3 months after the completion of prospective data collection
The area under the receiver operating characteristic curve (ROC-AUC) of the model for abnormal lesion detection
performance of anatomic site recognition
时间窗: Within 3 months after the completion of prospective data collection
The average precision (AP) of the model for recognizing nasopharyngeal and laryngeal anatomic sites
次要结局
- Comparison of diagnostic performance between the model and physicians(Within 3 months after the completion of prospective data collection)