NCT06096896进行中（未招募）不适用
The Efficacy and Safety of EOB-MRI Guided Microwave Ablation for Early HCC: A Multicenter, Prospective, Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- 5-years overall survival (OS) after MWA for early HCC
研究概览
简要总结
HCC is one of most common causes of cancer-related death in the world due to lately diagnosis by typical hallmarks which rely on completed arterialization. So it is important to earlier diagnose and treat hypovascular early HCC(eHCC). The aim of this study is to evaluate the efficacy and safety of microwave ablation for early HCC, also to explore the feasibility of EOB-MRI (Gd-EOB-DTPA enhanced MRI) guided ablation.
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
- •Age ≥ 18 years;
- •Patients with chronic liver disease who are at high/extremely high-risk of hepatocellular carcinoma;
- •EOB-MRI suggestive of confirmed or suspected eHCC (single lesion ≤ 2 cm or number of lesions ≤ 3 and maximum diameter ≤ 2 cm)
- •No previous history of hepatocellular carcinoma;
- •Not receiving any anti-cancer treatment;
- •Liver function Child-push A or B.
排除标准
- •Presence of lymph nodes or distant metastases;
- •Presence of liver metastases;
- •Prior malignancy;
- •Severe cardiopulmonary or renal dysfunction;
- •Suffering from uncorrectable coagulation dysfunction (prothrombin time > 25 seconds, prothrombin activity < 40%, platelet count ≤ 50x10^9/L);
- •Severe infectious lesions in the area of the puncture needle tract.
结局指标
主要结局
5-years overall survival (OS) after MWA for early HCC
时间窗: 5 years
Analyze the efficacy and safety of EOB-MRI-guided microwave ablation in the treatment of eHCC;
次要结局
- Rate of completed ablation after MWA(rate of completed ablation at one month)
研究者
Chengli Li
Director of imaging magnetic resonance interventional diagnosis and Treatment Department, Shandong Provincial Hospital
Shandong Provincial Hospital
研究点 (1)
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