跳至主要内容
临床试验/NCT05429190
NCT05429190Enrolling By Invitation不适用

Validation of a Short and Effective MRI Surveillance (SMS) Protocol for Hepatocellular Carcinoma Screening in Practice

Erasmus Medical Center6 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2023年11月7日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Céline van de Braak

PhD-student

Erasmus Medical Center

研究点 (6)

Loading locations...

相似试验