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

Phase 1

Recruiting

• Conditions: Gastrointestinal Polyp; Dysplasia; Gastrointestinal Carcinoma
• Interventions: Drug: Bev-ICG; Device: NIR-II fluorescence endoscopy platform

• Registration Number: NCT06430372
• Lead Sponsor: Institute of Automation, Chinese Academy of Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-20
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bev-ICG NIR-II Endoscopy	Bev-ICG	The patients will receive a topical administration of probe (Bev-ICG) during the endoscopy. Then fluorescence imaging will be performed to guide the detection.
Bev-ICG NIR-II Endoscopy	NIR-II fluorescence endoscopy platform	The patients will receive a topical administration of probe (Bev-ICG) during the endoscopy. Then fluorescence imaging will be performed to guide the detection.

Primary Outcome Measures

Name	Time	Method
Validation of NIR-II endoscope and probe targeting VEGF-A	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.

Trial Locations

Locations (1)

Lidan Fu; 🇨🇳 Beijing, Beijing, China