Study on the Quantitative Assessment of the Risk of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Using Multi-parameter Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- HCC incidence rate
研究概览
简要总结
Quantitative MRI scanning parameters such as T1 mapping, T2 mapping, T1ρ, and elastography are used, combined with clinical and laboratory indicators, to predict the risk of liver cancer in patients with cirrhosis.
详细描述
Retrospectively and prospectively collect T1 mapping, T2 mapping, T2* mapping, T1ρ, elastography and other multi-parameter MRI sequence images and clinical and laboratory examination data from patients with liver cirrhosis, and conduct 5-year clinical follow-up and monitoring of all enrolled patients. Whether patients develop hepatocellular carcinoma, patients are divided into liver cancer occurrence group and non-hepatocellular carcinoma group according to clinical follow-up results. Cox proportional hazard analysis is used to compare the differences in clinical characteristics, laboratory tests, imaging characteristics, quantitative MRI parameters and other variables between the two groups of patients. , and calculate the hazard ratio for each variable; assign a score to each covariate based on the proportion of the hazard ratio in the multivariable model, and develop a nomogram to predict HCC risk by the total score.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged over 18 years old;
- •Liver function Child-Pugh classification A or B;
- •Patients with chronic liver disease who meet the diagnostic criteria for high-risk groups of liver cancer in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)";
- •Equipped with Gd-EOB-DTPA enhanced MRI scan images, including T1 mapping, T2 mapping, T2* mapping, T1ρ and other sequences;
- •With 5-year follow-up data.
排除标准
- •Patients who are unable to undergo MRI scanning due to claustrophobia, abnormal renal function, etc.;
- •Patients who have undergone liver surgery in the past;
- •Patients with major diseases such as heart failure and tumors.
结局指标
主要结局
HCC incidence rate
时间窗: 5 years
Rate of HCC among enrolled patients
次要结局
未报告次要终点