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NCT Number: NCT06430372

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

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.

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Key information

Conditions

Gastrointestinal Carcinoma Dysplasia Gastrointestinal Polyp

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lidan Fu

Beijing, Beijing Municipality, 100190, China

Location status: Recruiting

Location contact

Lidan Fu

CONTACT

[email protected]

17754927702

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Validation of NIR-II endoscope and probe targeting VEGF-A

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lidan Fu

CONTACT

[email protected]

17754927702

Sponsors and collaborators

Lead sponsor

Institute of Automation, Chinese Academy of Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 28, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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