Using a special fluorescent probe to improve endoscopy for gastrointestinal issues
Study of Vascular Endothelial Growth Factor A Targeting NIR-II Fluorescence in the Endoscopy of Gastrointestinal Tract
This study is testing a new fluorescent probe during endoscopy to see if it can help doctors find abnormal tissues in the gastrointestinal tract more accurately.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Institute of Automation, Chinese Academy of Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06430372 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel approach to enhance the detection of abnormal tissues in the gastrointestinal tract during endoscopy using a VEGF-A targeting fluorescent probe and a NIR-II fluorescence endoscope. The main goals are to translate this advanced imaging technique into clinical practice, validate the effectiveness of the topical probe in adhering to abnormal tissues, and assess the safety of this method. Participants will be those scheduled for clinically-indicated endoscopies and will be monitored for potential follow-up. The study aims to provide a more accurate and effective way to identify gastrointestinal lesions.
Who should consider this trial
Good fit: Ideal candidates include individuals with known or suspected gastrointestinal lesions who are scheduled for an endoscopy.
Not a fit: Patients with known allergies to ICG or those with significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of gastrointestinal cancers and other abnormalities.
How similar studies have performed: While this approach is innovative, similar studies using advanced imaging techniques have shown promise in improving detection rates in other areas of medicine.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Lidan Fu — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Lidan Fu
- Email: fulidan2021@ia.ac.cn
- Phone: 17754927702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.