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

Study of Vascular Endothelial Growth Factor A Targeting NIR-II Fluorescence in the Endoscopy of 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 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 Overview

• Status: Recruiting
• Conditions: Dysplasia; Gastrointestinal Polyp; Gastrointestinal Carcinoma
• Intervention / Treatment: Drug: Bev-ICG; Device: NIR-II fluorescence endoscopy platform

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lidan Fu; Phone Number: 17754927702; Email: fulidan2021@ia.ac.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100190
      • Recruiting
      • Lidan Fu
      • Contact: Lidan Fu; Phone Number: 17754927702; Email: fulidan2021@ia.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Bev-ICG; Probe targeting VEGF-A that is topically administrated during the endoscopy; Device: NIR-II fluorescence endoscopy platform; An endoscopic detection device which can detect and visualize NIR-II fluorescent signal during the endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During endoscopy

Collaborators and Investigators

• Sponsor: Institute of Automation, Chinese Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NIR-II-ENDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No