Hepatocyte-specific Versus Extracellular Contrast Agents for Liver MRI: Prospective, Intra-individual Comparison of Diagnostic Performance for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Specificity
研究概览
简要总结
Adult patients with chronic hepatitis B and cirrhosis of any etiology who are found to have suspected liver cancer are potentially eligible for the study. All enrolled patients will undergo two MRI scans using two different contrast agents. The type of contrast agent for the 1st MRI will be performed using hepatocyte-specific contrast agent. The participant will undergo the 2nd MRI using extracellular contrast agent. The MRI examinations will be independently interpreted by two different radiologists. The radiologists will evaluate focal hepatic lesions and categorize them according to the LI-RADS v2018 and EASL 2018. Once the diagnosis is made, the participants will be provided with the standard of care. After the initial treatment, the participants will be followed up with multi-phasic dynamic contrast-enhanced CT every 3 or 6 months for at least 2 years. Based on the prospectively written radiology reports, the diagnostic performances will be calculated and compared between MRI with hepatocyte-specific contrast agent and MRI with extracellular contrast agent, using the pathology and clinical criteria as the reference standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 20 years
- •HBsAg (+) with chronic hepatitis or cirrhosis, anti-HCV (+) with cirrhosis, or cirrhosis of any etiology
- •The presence of cirrhosis will be determined based on the histologic or radiologic findings, including liver surface nodularity, margin blunting, segmental hypertrophy/atrophy, and findings secondary to portal hypertension (i.e., splenomegaly, esophageal or gastric varices, ascites, or reverse portal vein flow).
- •Child-Pugh class A or B
- •Up to three suspicious focal lesions between 10 mm and 30 mm found on US, CT, or MRI
- •Patients with a history of HCC treated by surgery or tumor ablation could be included, but only new nodules at a distance of > 2 cm from previously treated lesions were considered.
排除标准
- •Currently pregnant or lactating
- •Risk group for the use of gadolinium-enhanced MRI including severely decreased renal function (stage 4 or 5 chronic renal failure with eGFR ˂ 30 mL/min/1.73 m2), claustrophobia
- •Patients with history of chemoembolization or systemic treatment for liver cancer
结局指标
主要结局
Specificity
时间窗: an expected average of 2 weeks
The comparison of specificity between MRI using hepatocyte-specific contrast agent and extracellular contrast agent in the diagnosis of hepatocellular carcinoma. The per-lesion sensitivity will be compared using McNemar's test.
Sensitivity
时间窗: an expected average of 2 weeks
The comparison of sensitivity between MRI using hepatocyte-specific contrast agent and extracellular contrast agent in the diagnosis of hepatocellular carcinoma The per-lesion sensitivity will be compared using McNemar's test.
次要结局
- Inter-reader agreement between two radiologists(an expected average of 2 weeks)