An Evaluation Study of GPC3 Targeted Fluorescence Imaging to Guide the Surgery of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- HCC lesions
研究概览
简要总结
This study is to evaluate whether intraoperative fluorescence imaging targeting GPC3 can aid improve the surgical accuracy of hepatocellular carcinoma.
The main purposes of this study include:
① To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the GPC-3 targeted fluorophore.
② To validate the safety and effectiveness of the designed GPC-3 targeted fluorophore for clinical application.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have been diagnosed with hepatocellular carcinoma.
- •Planned to receive hepatectomy.
- •Liver function Child-Pugh A/B.
- •GPC-3 was validated highly expressed preoperatively.
- •Aged 18 to 75, and the expected lifetime is longer than 6 months.
- •Approved to sign the informed consent.
排除标准
- •Allergic to IRDye
- •Enrolled in other trials in the past 3 months.
- •Another malignant tumor was 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
Anti-GPC3-IRDye800CW Intraoperative Fluorescence
The patients will receive an injection of fluorophore (Anti-GPC3-IRDye800CW) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection.
干预措施: Anti-GPC3-IRDye800CW (Drug)
结局指标
主要结局
HCC lesions
时间窗: During hepatocellular resection surgery.
Numbers of intraoperatively detected hepatocellular carcinoma lesions.
次要结局
未报告次要终点
研究者
Zeyu Zhang, PHD
Principal Investigator
Chinese Academy of Sciences