Artificial Intelligence Detection of Bladder Tumors Under Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- intersection over union
研究概览
简要总结
The goal of this clinical trial is to learn if the AI algorithm can detect bladder tumors better than urologists under cystoscopy. It will also train the AI algorithm for bladder tumor detection. The main question it aims to answer is:
Can AI algorithm achieve IOU value, precision, recall, false negative rate of bladder tumor detection similar to that of urologists? The cystoscopy video will be annotated by AI and urologists. Researchers will compare AI algorithm to urologists to see if Al algorithm has a similar capability as urologists do.
详细描述
- Research Background Bladder cancer is the ninth most common malignancy worldwide, with an estimated 430,000 new cases diagnosed annually. The standard diagnosis and monitoring of bladder cancer rely on white light cystoscopy (WLC), with over 2 million cystoscopies performed annually in the United States and Europe. Due to the high recurrence rate of bladder cancer, frequent monitoring and intervention are necessary.
Early detection and complete resection of non-muscle invasive bladder cancer can reduce recurrence and progression. However, up to 40% of patients with multifocal disease do not achieve complete resection during the initial transurethral resection of bladder tumor (TURBT). Many papillary tumors and flat lesions are difficult to identify through WLC. There is an urgent need for cost-effective, non-invasive, and user-friendly adjunct imaging technologies to address the diagnostic deficiencies of WLC.
Recent advancements in deep learning-based automated image processing may provide new solutions to the limitations of cystoscopy. Convolutional neural networks (CNNs) possess the ability to learn complex relationships and integrate existing knowledge into models, showing potential applications across various fields, including bladder tumor diagnosis. We employed the HRNet algorithm, a convolutional neural network, for enhanced bladder tumor detection. 2. Research Objectives We aim to explore the potential application of AI in urological tumors by collecting cystoscopy videos from patients undergoing cystoscopy. These videos include bladder tumors will be annotated manually by urologists, then, the AI algorithm will be used to recognize the bladder tumors. 3. Research Methods This is a multicenter, retrospective, observational study. 4. Research Process 4.1 Patient Cohort Inclusion criteria: 1. The patients who had bladder tumor and received WLC or TURBT, and the full-length surgery video is available.
Exclusion criteria: 1. The video is too blurry to distinguish the normal bladder wall and bladder tumor. 2. Lack of the appearance of bladder tumor before resection. 3. Lack of informed consent.
Patient information in the videos will not be shown. Videos from the initially recruited 200 bladder tumor patients will be used for algorithm development. Videos from an additional 100 patients are used for algorithm validation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient who receives cystoscopy and the cystoscopy video is available, and one or multiple bladder lesions can be observed in the cystoscopy.
排除标准
- •The patient whose cystoscopy is not clear enough to analyze.
结局指标
主要结局
intersection over union
时间窗: From Jan 1st 2024 to Dec 31st 2033
The overlapping area of the actual bladder lesion and detected bladder lesion divided by their combined areas.
次要结局
未报告次要终点
