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

ConditionsGastrointestinal Carcinoma Dysplasia Gastrointestinal Polyp

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorInstitute of Automation, Chinese Academy of Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Known or suspected gastrointestinal lesions.

Scheduled for a clinically-indicated endoscopy.

Mentally competent person, 18 years or older.

Approved to sign the informed consent.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Bev-ICG
Drug
Probe targeting VEGF-A that is topically administrated during the endoscopy
NIR-II fluorescence endoscopy platform
Device
An endoscopic detection device which can detect and visualize NIR-II fluorescent signal during the endoscopy

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Bev-ICG NIR-II EndoscopyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

During endoscopy

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Automation, Chinese Academy of Sciences

Lead sponsor

Source ClinicalTrials.gov

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