NCT05394246招募中不适用
Intraoperative Liver Tumor Imaging Using Fluorescent-labeled Human IgG
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tumor imaging precision
研究概览
简要总结
This study is to evaluate whether intraoperative fluorescence imaging using fluorescent-labeled IgG probe (FluoAB) can help distinguish the tumor and the liver cirrhosis (or the liver parenchyma).
The main purposes of this study include:
- To validate the safety and effectiveness of using FluoAB in hepatic surgery.
- To raise the surgical precision with guidance by FluoAB fluorescence imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Patients who have been diagnosed with liver tumor.
- •Planned to receive hepatectomy.
- •Liver function Child-Pugh A/B.
- •The expected lifetime is longer than 6 months.
- •Approved to sign the informed consent.
排除标准
- •Enrolled in other trials in the past 3 months.
- •Metastatic lesions were found.
- •Undesirable function of heart, lung, kidney, or any other organs.
- •Unable to tolerate a hepatectomy.
- •The researchers considered inappropriate to be included.
研究组 & 干预措施
FluoAB intraoperative fluorescence imaging
Experimental
The patients will receive an injection of FluoAB. Surgery will be performed with guidance by FluoAB fluorescence imaging.
干预措施: FluoAB (Drug)
结局指标
主要结局
Tumor imaging precision
时间窗: Update with an average of 2 weeks.
Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging.
Tumor lesions
时间窗: Immediately after the hepatic surgery.
Numbers of intraoperatively detected tumor lesions.
次要结局
未报告次要终点
研究者
Zeyu Zhang, PHD
Principal Investigator
Chinese Academy of Sciences
研究点 (1)
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