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

Dysplasia Clinical Trial

Official title:

Study of Vascular Endothelial Growth Factor A Targeting NIR-II Fluorescence in the Endoscopy of Gastrointestinal Tract

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06430372
• Other study ID #: NIR-II-ENDO
• Status: Recruiting
• Phase: Phase 1
• Start date: May 30, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2024
• Source: Institute of Automation, Chinese Academy of Sciences
• Contact: Lidan Fu
• Phone: 17754927702
• Email: fulidan2021[@]ia.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysplasia
• Gastrointestinal Carcinoma

Intervention

Drug:
• Bev-ICG
Probe targeting VEGF-A that is topically administrated during the endoscopy

Device:
• NIR-II fluorescence endoscopy platform
An endoscopic detection device which can detect and visualize NIR-II fluorescent signal during the endoscopy

Locations

Country	Name	City	State
China	Lidan Fu	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Automation, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During endoscopy