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【ChiCTR1900022389】CEUS with Sonazoid to Detect Small HCCs

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基本信息

登记号

ChiCTR1900022389

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2019-04-09

临床申请受理号

靶点

适应症

肝細胞癌

试验通俗题目

CEUS with Sonazoid to Detect Small HCCs

试验专业题目

Contrast-enhanced Ultrasound with Perfluorobutane (Sonazoid) to Detect Small Hepatocellular Carcinomas – A Prospective Cohort Study

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联系人邮编

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临床试验信息

试验目的

To investigate the added value of S-CEUS to conventional B-mode US in HCC; surveillance of high-risk patients for the detection and characterization of focal liver lesions.

试验分类

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试验类型

诊断试验诊断准确性

试验分期

诊断试验新技术

随机化

N/A

盲法

N/A

试验项目经费来源

Local research grant

试验范围

目标入组人数

实际入组人数

第一例入组时间

2019-07-02

试验终止时间

2020-07-02

是否属于一致性

入选标准

Patients will be eligible for the study if they fulfill all of the followings criteria: 1) they are at least 18 years old; 2) with known chronic liver disease and liver cirrhosis; 3) On ultrasonography, their liver shows nodular liver parenchyma; 4) For chronic hepatitis B patients, their LSM-HCC score should be ≥11 (factors and scores please refer below) OR for other chronic liver diseases, the liver stiffness measurement (LSM) of the patients should be ≥12.0 kPa; and 5) All the patients must agree to participate in the study with informed written consent. Factors and their respective scores of LSM-HCC score (11) are listed below. 1. Age [>50 years, score +10] and [age 50 or less, score 0]; 2. Albumin [35g/l or less, score +1] and [albumin > 35g/l, score 0]; 3. HBV DNA [> 200,000 IU/ml, score +5] and [200,000 IU/ml or less, score 0]; 4. Liver stiffness measurement [8.0 kPa, score 0], [ 8.1-12.0 kPa, score +8] and [> 12.0 kPa, score +14]. *Total score ranges from 0 to 30. HBV = hepatitis B virus.；

排除标准

1. Child-Pugh score 8 or above; 2. Previous or current hepatocellular carcinoma; 3. Portal vein thrombosis; 4. Previous liver surgery; 5. Liver transplantation; 6. Contraindications to transient elastography (e.g. pregnancy, previous pacemaker implantation); 7. Contraindications to Sonazoid contrast; 8. Contraindications to Primovist contrast; 9. Contraindications to magnetic resonance imaging (e.g. metallic implants, pacemaker implantation); 10. Refusal to consent.；

研究者信息

研究负责人姓名

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试验机构

香港中文大學

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