TCTR20201230003已完成2 期
Artificial intelligence assisting physicians in detection of focal liver lesions from real-time ultrasonography
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 676
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •Patients who meet diagnostic criteria of the following focal liver lesions:
- •1. Hepatocellular carcinoma (HCC). Pathology results will be considered first. If there is no pathology result, CT and/or MRI results within 3 months before or after the index ultrasound date will be considered.
- •2. Liver cysts. Simple cysts can be diagnosed solely by ultrasound. However, diagnosis of complicated cysts requires confirmatory CT and/or MRI. Additionally, size of the lesion must also be stable during at least 2-year interval.
- •3. Hemangioma. CT/MRI results will be used as gold standard for diagnosis. If there is no CT/MRI, typical hemangioma (round homogeneous bright hyperechoic lesion on ultrasound) can be diagnosed by follow-up criteria, i.e., at least 2 ultrasound studies demonstrating size stability during at least 2-year interval.
- •4. Focal fatty sparing. CT/MRI will be considered first. If there is no CT/MRI, ultrasound diagnosis will be accepted only if the lesion has typical shape (geographic-shaped homogeneous hypoechoic lesion), and is located in typical area of the liver (peri-portal or peri-gallbladder). Size of the lesion must also be stable during at least 2-year interval.
- •5. Focal fatty infiltration. CT/MRI will be considered first. If there is no CT/MRI, ultrasound diagnosis will be accepted only if the lesion has typical shape (geographic-shaped homogeneous hyperechoic lesion), and is located in typical area of the liver (peri-portal or peri-gallbladder). Size of the lesion must also be stable during at least 2-year interval.
- •Patients without focal liver lesions, by one of the following criteria:
- •1. has CT/MRI within 6 months before or after ultrasound performing in the study arms, confirming that there is no focal liver lesion.
- •2. At least 2 ultrasound studies demonstrating no focal liver lesion, with at least one ultrasound study performed within 6 months before or after ultrasound performing in the study arms.
排除标准
- •1. Patients with polycystic liver disease
- •2. HCCs previously treated by locoregional methods
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