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

NCT06430372 | Recruiting Phase 1 DMC

• 1 other identifier: NIR-II-ENDO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.To translate the NIR-II approach into the endoscopy, and understand its advantages and limitations on detecting abnormal tissues in gastrointestinal.
2. 2.To validate whether topical administration of a targeting probe can stick to abnormal tissues and be detected by the NIR-II endoscope.
3. 3.To validate the safety and effectiveness of the topical administration of VEGF-A targeting probes for clinical application.

Conditions

Gastrointestinal Carcinoma; Dysplasia; Gastrointestinal Polyp

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bev-ICG NIR-II Endoscopy

EXPERIMENTAL

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; Device: NIR-II fluorescence endoscopy platform

Interventions

Bev-ICG DRUG

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

Bev-ICG NIR-II Endoscopy

NIR-II fluorescence endoscopy platform DEVICE

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

Bev-ICG NIR-II Endoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Automation, Chinese Academy of Sciences: lead

Study Sites (1)

Lidan Fu

Beijing, Beijing Municipality, 100190, China

RECRUITING

Central Study Contacts

Lidan Fu

CONTACT

17754927702; fulidan2021@ia.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: July 20, 2023
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)