Study of VEGF-A Targeting NIR-II Fluorescence Endoscopy in the Gastrointestinal Tract
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bev-ICG, NIR-II fluorescence endoscopy platform.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Carcinoma, Dysplasia, Gastrointestinal Polyp. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of Vascular Endothelial Growth Factor A Targeting NIR-II Fluorescence in the Endoscopy of Gastrointestinal Tract
Overview
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.
Interventions
- 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
Primary outcome measures
- Validation of NIR-II endoscope and probe targeting VEGF-A [Time frame: During endoscopy]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
China · 1 center
- Lidan Fu — Beijing
Identifiers
NCT: NCT06430372 · NIR-II-ENDO