Validation of a Short and Effective MRI Surveillance (SMS) Protocol for Hepatocellular Carcinoma Screening in Practice
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 470
- 试验地点
- 6
- 主要终点
- Increased sensitivity for HCC detection
研究概览
简要总结
The investigators will assess implementation of the proposed SMS protocol as a surveillance tool in patients at high risk of developing HCC in a prospective multicenter study.
详细描述
Over the past 20 years, the prevalence of HCC has been growing extensively. HCC makes up for 75-85% of primary liver cancers and has a poor prognosis with a 5-year survival rate lower than 20%. The incidence of HCC is higher in patients diagnosed with hepatitis and/or cirrhosis. The current guidelines recommend a bi-annual US screening of this patient group. However, recent meta-analysis showed that the sensitivity of such US surveillance for detecting early stage HCC is merely 47%. In addition, early detection of small HCC lesions (with a diameter less than 2 cm) will provide a higher survival chance. It is therefore of major importance to develop a better surveillance tool.
The use of MRI should be considered as a surveillance tool for this patient group. In comparison to US, MRI come with high cost, long duration of the scan, limited availability and a potential risk related to the use of contrast agents. The investigators have developed and validated a short MRI surveillance (SMS) protocol for HCC screening in high-risk patients. This protocol has been evaluated among a database of 215 patients. In this prospective, multicenter study, the investigators will evaluate the value of the SMS protocol in a high-risk patient group and they will assess the cost-effectiveness of the SMS protocol as a surveillance tool with respect to a bi-annual US screening.
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
- 否
入选标准
- •Male and female patients above 18 years of age
- •High-risk patients with cirrhosis and/or hepatitis
排除标准
- •Patients below the age of 18 years
- •Patients who will not sign the informed consent form
- •Patients with general contra-indications for undergoing MRI examination
结局指标
主要结局
Increased sensitivity for HCC detection
时间窗: 3 years
Detection of HCC using the SMS protocol will be compared to US surveillance
次要结局
- Cost-effectiveness analysis of SMS protocol(2 years)
研究者
Céline van de Braak
PhD-student
Erasmus Medical Center
