Study of VEGF-A Targeting NIR-II Fluorescence Endoscopy in the Gastrointestinal Tract

Phase 1RecruitingNCT06430372

Institute of Automation, Chinese Academy of Sciences30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Gastrointestinal Carcinoma Dysplasia Gastrointestinal Polyp

Interventions

Bev-ICGDRUG

Probe targeting VEGF-A that is topically administrated during the endoscopy

NIR-II fluorescence endoscopy platformDEVICE

An endoscopic detection device which can detect and visualize NIR-II fluorescent signal during the endoscopy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Validation of NIR-II endoscope and probe targeting VEGF-A

Demonstrate the feasibility of using the NIR-II endoscope and VEGF-A targeting fluorescent probe to image abnormal tissues of the gastrointestinal tract.

Time frame: During endoscopy