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

NCT ID: NCT06430372

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2026-05-30

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.

Conditions

Gastrointestinal Carcinoma; Dysplasia; Gastrointestinal Polyp

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bev-ICG

Intervention Type: DRUG

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

NIR-II fluorescence endoscopy platform

Intervention Type: DEVICE

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

Interventions

Bev-ICG

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

Intervention Type: DRUG

NIR-II fluorescence endoscopy platform

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Automation, Chinese Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zhenhua Hu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lidan Fu

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lidan Fu

Role: CONTACT

fulidan2021@ia.ac.cn

17754927702

Facility Contacts

Lidan Fu

Role: primary

fulidan2021@ia.ac.cn

17754927702

Other Identifiers

NIR-II-ENDO

Identifier Type: -

Identifier Source: org_study_id