ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery of HCC Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- HCC lesions
研究概览
简要总结
In this study, the investigators will detect hepatocellular carcinoma lesions using fluoescence imaging with ITGA6 targeting probes during tumor resection surgery. The aim is to evaluate wether intraoperative fluorescence imaging targeting ITGA6 can help to improve the detction effect of hepatocellular carcinoma, and finally help the accurate surgical resection.
The main purposes of this study include:
- To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the ITGA6 targeting probe.
- To validate the safety and effectiveness of the proposed ITGA6 targeting probes 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 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 hepatocellular carcinoma.
- •Planned to receive hepatectomy.
- •Liver function Child-Pugh A.
- •ITGA6 was validated highly expressed preoperatively.
- •Aged 18 to 80, and the expected lifetime is longer than 6 months.
- •Approved to sign the informed consent.
排除标准
- •Allergic to Cy
- •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
RDCy7 Intraoperative Fluorescence
The patients will receive an injection of fluorophore (RDCy7) before the surgery. Then intraoperative fluorescence imaging will be performed to guide lesion resection.
干预措施: RD-Cy7 fluorophore (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
Zhenhua Hu
Professor
Institute of Automation, Chinese Academy of Sciences