RecruitingPhase 1NCT06430372

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

Sponsor

Institute of Automation, Chinese Academy of Sciences

Enrollment

30 participants

Start Date

Jul 20, 2023

Study Type

INTERVENTIONAL

Conditions

Dysplasia Gastrointestinal Carcinoma Gastrointestinal Polyp

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria7

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.