Detection of Ovarian Cancer Using an Artificial Intelligence Enabled Transvaginal Ultrasound Imaging Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000
- 主要终点
- diagnostic accuracy
研究概览
简要总结
Ovarian cancer is relatively rare but fatal with an annual incidence rate of 11.8 per 100 000 and a high mortality-to-incidence ratio of >0.6. The modest diagnostic accuracy of TVU has risen some concerns about the over-treatment.Now, with the development of artificial intelligence (AI), we may have a better chance to interpret TVU imagines with high efficiency, reproducibility and accuracy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women scheduled for Transvaginal Ultrasound examination for adnexal lesions;
- •Women aged over 18 years old;
- •Women willing to participant in this study evidenced by signing the informed consent.
排除标准
- •Women without adnexa for any reasons at the time of Transvaginal Ultrasound examination, including but not limited to receiving surgical removal for adnexa;
- •Women with a pathologic diagnosis of ovarian cancer before the Transvaginal Ultrasound examination;
- •Women with mental abnormal;
- •Women did not cooperate or participate in other clinical trials;
- •Pregnant or lactating women.
研究组 & 干预措施
Transvaginal Ultrasound diagnosis
radiologists interpretTransvaginal Ultrasound images without the help of Artificial Intelligence (AI) algorithm
AI enabled Transvaginal Ultrasound diagnosis
radiologists interpretTransvaginal Ultrasound images with the help of Artificial Intelligence algorithm
干预措施: Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm (Diagnostic Test)
结局指标
主要结局
diagnostic accuracy
时间窗: 2 years
diagnostic accuracy comparison between Transvaginal Ultrasound diagnosis with and without Artificial Intelligence algorithm for ovarian cancer
次要结局
- time cost for Transvaginal Ultrasound image interpretation(2 years)
研究者
Qinglei Gao
Clinical Professor
Tongji Hospital