跳至主要内容
临床试验/NCT07590284
NCT07590284尚未招募不适用

A Multicenter, Prospective Study of Sonazoid CEUS for Early HCC Surveillance in a High-risk Population

Tianjin Third Central Hospital1 个研究点 分布在 1 个国家目标入组 556 人开始时间: 2026年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
556
试验地点
1
主要终点
Detection rate

研究概览

简要总结

This study is a multicenter, prospective study. In this study, enrolled subjects are cirrhotic patients of any etiology. The US and Sonazoid CEUS monitoring strategy was performed for cirrhotic patients: US and AFP joint with Sonazoid CEUS every 4 to 6 months, and combined CECT/CEMRI every 12 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cirrhotic patients diagnosed clinically or radiologically due to any etiology (patients with cirrhosis due to congenital fibrosis and patients with cirrhosis due to vascular causes were excluded).
  • Age 18-80 years old.
  • Able to receive regular imaging, including US, CEUS, and CECT or CEMRI or EOB-MRI, according to the diagnostic and treatment procedures.
  • Obtained informed consent from the patient.

排除标准

  • Patients with pathologic or enhanced imaging of established HCC who have not undergone curative treatment.
  • Patients with known hypersensitivity to enhanced imaging contrast agents.
  • Patients with severe cardiac, pulmonary or renal insufficiency that precludes CECT or CEMRI or EOB-MRI.
  • Lactating and pregnant women.
  • Those who are not suitable for enrollment as assessed by the investigator.
  • Patients with egg or egg-product allergy, or with severe right-to-left cardiac shunt or intrapulmonary shunt.

研究组 & 干预措施

Sonazoid CEUS and US for screening

Other

Sonazoid CEUS examination

干预措施: Sonazoid CEUS (Diagnostic Test)

结局指标

主要结局

Detection rate

时间窗: 3-year

To compare the detection rate of Sonazoid CEUS and US for early HCC

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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