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

Institute of Automation, Chinese Academy of Sciences

Status and phase: Enrolling; Phase 1

Conditions: Dysplasia; Gastrointestinal Polyp; Gastrointestinal Carcinoma

Treatments: Drug: Bev-ICG; Device: NIR-II fluorescence endoscopy platform

Study type: Interventional

Funder types: Other

Identifiers

NCT06430372

NIR-II-ENDO

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Bev-ICG NIR-II Endoscopy

Experimental group

Description:

The patients will receive a topical administration of probe (Bev-ICG) during the endoscopy. Then fluorescence imaging will be performed to guide the detection.

Treatment:

Device: NIR-II fluorescence endoscopy platform

Drug: Bev-ICG