NCT04123340已完成2 期
Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation
Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of the use of co-registration software (>80%)
研究概览
简要总结
A pre- and postablation scan will be made intraprocedurally to investigate the feasibility of intraprocedural ablation verification assessment using coregistration software
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
盲法说明
post-procedural an assessment will be done of the ablation completeness using registration software. The actual ablation verification will be done qualitatively by the treating physician.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 yrs or above
- •HCC very early (0) or early stage (A) according to the BCLC staging system
- •Either de novo or recurrent HCC (prior locoregional therapy is allowed in the study)
- •Candidate for percutaneous thermal ablation as discussed in a multidisciplinary tumor board. Ablation as 'bridge-to-transplant' is allowed in the study
排除标准
- •Estimated GFR <30 ml/min
- •Morbid obesitas or any pulmonary condition that is a contraindication to prolonged apnea and high jet-ventilation
- •Child Pugh C
- •Portal vein tumor invasion
- •Extrahepatic metastasis
- •Uncorrectable coagulopathy
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Inability or unwillingness to give informed consent
结局指标
主要结局
Feasibility of the use of co-registration software (>80%)
时间窗: 1 year
The proportion of patients in whom reliable co-registration of pre- and post-ablation CT images is feasible
次要结局
- The time that is required for CT-CT co-registration(1 year)
- Inter and intra-observer variability(1 year)
- Quantitatively assessed ablation margin(1 year)
研究者
MCBurgmans
Principal Investigator
Leiden University Medical Center
研究点 (2)
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