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临床试验/NCT05445973
NCT05445973已完成不适用

Real-Time Contrast-Enhanced Ultrasonography-CT/MRI Fusion Guidance for Percutaneous Radiofrequency Ablation of Inconspicuous, Small Liver Tumors

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
248
试验地点
2
主要终点
Local tumor progression rate

研究概览

简要总结

Contrast-enhanced ultrasonography (CEUS)-CT/MRI fusion imaging substantially improved the visibility of small tumors that were inconspicuous on both US and US-CT/MRI fusion imaging, contributing to successful percutaneous radiofrequency ablation.

详细描述

Percutaneous radiofrequency ablation (RFA) has been widely implemented as a curative treatment for liver malignancies. The overall survival post-RFA is comparable to that of surgical outcomes for small hepatocellular carcinomas (HCCs) (≤ 3 cm). US guidance for RFA is common in Asia because the real-time capability of US allows precise electrode placement. However, precisely targeting small liver malignancies with poor sonographic conspicuity in US-guided RFA is often challenging. To solve this problem, CEUS or real-time fusion imaging (FI) of US and CT/MRI have been used. Both approaches have been reported to improve the confidence for tumor localization in RFA for small HCCs with poor B-mode US visibility. However, when an index tumor is entirely invisible on B-mode US, neither method is ideal, especially for multiple-electrode RFA, due to inherent registration errors on FI or insonation-induced bubble destruction on CEUS with SonoVue. Therefore, there is a clinical need to compensate for the inherent registration errors of US-CT/MRI FI for inconspicuous tumors on both US and US-CT/MRI FI.

Recent studies reported that after adding CEUS using Sonazoid (GE Healthcare, Waukesha, WI, USA) or SonoVue to FI, 83.3% to 90% of target liver cancers that were initially difficult to visualize on FI became conspicuous, allowing them to be directly targeted for RFA. However, these studies had limitations, including a retrospective study design, a small sample size (< 30 inconspicuous tumors), or a short-term follow-up (< 1 year). Furthermore, no prospective study has explored the value of CEUS-CT/MRI FI, using both SonoVue and Sonazoid as contrast agents, for localizing index tumors and guiding RFA procedures in patients with inconspicuous tumors on B-mode US and reported its therapeutic impact on local tumor control.

Therefore, the present study investigated whether CEUS-CT/MRI FI improved the visibility of small (≤ 3 cm) primary and secondary liver tumors that were invisible or difficult to visualize on B-mode US for percutaneous RFA.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • inconspicuous or invisible index tumors for ablation on US
  • tumor size ≤ 3 cm
  • pathologic diagnosis of primary or secondary liver malignancy or imaging-based diagnosis of HCC according to the American Association for the Study of Liver Disease guidelines or viable HCC according to the Liver Imaging Reporting and Data System treatment response algorithm
  • consideration of curative-intent RFA

排除标准

  • well-visible tumors (visibility score of 3 or 4) on the planning B-mode US
  • the absence of available data from multiphase CT or MRI performed in the 3-month pre-procedure period
  • poor quality registration of US-CT/MRI fusion imaging and RFA planned with palliative intent
  • contraindications for the conventional RFA procedure at the authors' institution, which are uncontrollable coagulopathy (platelet count < 50,000/μL or international standard ratio ≥ 1.6), a low level of cooperation, impracticality of sedation, portal vein thrombus, the tumor abutting the portal vein, or larger bile ducts than the segmental branches

结局指标

主要结局

Local tumor progression rate

时间窗: 12 months after the radiofrequency ablation

Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI)

次要结局

  • Technical success rate of radiofrequency ablation using contrast-enhanced US-CT/MRI fusion image(Immediately after radiofrequency ablation)

研究者

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

Jeong Min Lee

Professor

Seoul National University Hospital

研究点 (2)

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