Study of Vascular Endothelial Growth Factor A Targeting NIR-II Fluorescence in the Endoscopy of Gastrointestinal Tract
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Validation of NIR-II endoscope and probe targeting VEGF-A
研究概览
简要总结
In this study, the investigators are studying new ways to look for abnormal tissues of the gastrointestinal tract during an endoscopy. We are using a VEGF-A targeting fluorescent probe and a NIR-II fluorescent endoscope to help detect abnormal tissues that are hard to see by the naked eye.
The main purposes of this study include:
- To translate the NIR-II approach into the endoscopy, and understand its advantages and limitations on detecting abnormal tissues in gastrointestinal.
- To validate whether topical administration of a targeting probe can stick to abnormal tissues and be detected by the NIR-II endoscope.
- To validate the safety and effectiveness of the topical administration of VEGF-A 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
- Screening
- 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
- 否
入选标准
- •Known or suspected gastrointestinal lesions.
- •Scheduled for a clinically-indicated endoscopy.
- •Mentally competent person, 18 years or older.
- •Approved to sign the informed consent.
- •Adequate potential for follow-up.
排除标准
- •Subjects with known allergy or negative reaction to ICG or derivatives.
- •Undesirable function of heart, lung, kidney, or any other organs.
- •Enrolled in other trials in the past 3 months.
- •Pregnant or trying to conceive.
- •Unable to tolerate an endoscopy.
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- •The researchers considered inappropriate to be included.
研究组 & 干预措施
Bev-ICG NIR-II Endoscopy
The patients will receive a topical administration of probe (Bev-ICG) during the endoscopy. Then fluorescence imaging will be performed to guide the detection.
干预措施: Bev-ICG (Drug)
Bev-ICG NIR-II Endoscopy
The patients will receive a topical administration of probe (Bev-ICG) during the endoscopy. Then fluorescence imaging will be performed to guide the detection.
干预措施: NIR-II fluorescence endoscopy platform (Device)
结局指标
主要结局
Validation of NIR-II endoscope and probe targeting VEGF-A
时间窗: During endoscopy
Demonstrate the feasibility of using the NIR-II endoscope and VEGF-A targeting fluorescent probe to image abnormal tissues of the gastrointestinal tract.
次要结局
未报告次要终点
研究者
Zhenhua Hu
Professor
Institute of Automation, Chinese Academy of Sciences