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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06430372

Enrollment

Registered

2024-05-28

Start date

2023-07-20

Completion date

2026-05-30

Last updated

2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysplasia, Gastrointestinal Carcinoma, Gastrointestinal Polyp

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.

Interventions

DRUGBev-ICG

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

DEVICENIR-II fluorescence endoscopy platform

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactLidan Fu

fulidan2021@ia.ac.cn17754927702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026