Study of VEGF-A Targeting NIR-II Fluorescence Endoscopy in the Gastrointestinal Tract
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 stu
| Condition(s) | Gastrointestinal Carcinoma, Dysplasia, Gastrointestinal Polyp |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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: 1. To translate the NIR-II approach into the endoscopy, and understand its advantages and limitations on detecting abnormal tissues in gastrointestinal. 2. To validate whether topical administration of a targeting probe can stick to abnormal tissues and be detected by the NIR-II endoscope. 3. To validate the safety and effectiveness of the topical administration of VEGF-A targeting probes for clinical application. |
| Who can participate | Inclusion Criteria: * 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. Exclusion Criteria: * 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. |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Institute of Automation, Chinese Academy of Sciences |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2023-07-20 |
| NCT ID | NCT06430372 |
| Official listing | https://clinicaltrials.gov/study/NCT06430372 |