## Protocol Section
### Identification Module
**NCT ID:** NCT06430372

**Brief Title:** Study of VEGF-A Targeting NIR-II Fluorescence Endoscopy in the Gastrointestinal Tract

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

#### Organization Study ID Info
**ID:** NIR-II-ENDO
#### Organization
**Class:** OTHER
**Full Name:** Institute of Automation, Chinese Academy of Sciences
### Status Module
#### Completion Date
**Date:** 2026-05-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Institute of Automation, Chinese Academy of Sciences

#### Responsible Party

**Investigator Affiliation:** Institute of Automation, Chinese Academy of Sciences

**Investigator Full Name:** Zhenhua Hu

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Gastrointestinal Carcinoma

- Dysplasia

- Gastrointestinal Polyp

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SCREENING

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The patients will receive a topical administration of probe (Bev-ICG) during the endoscopy. Then fluorescence imaging will be performed to guide the detection.

**Intervention Names:**

- Drug: Bev-ICG

- Device: NIR-II fluorescence endoscopy platform

**Label:** Bev-ICG NIR-II Endoscopy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bev-ICG NIR-II Endoscopy

**Description:** Probe targeting VEGF-A that is topically administrated during the endoscopy

**Name:** Bev-ICG

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Bev-ICG NIR-II Endoscopy

**Description:** An endoscopic detection device which can detect and visualize NIR-II fluorescent signal during the endoscopy

**Name:** NIR-II fluorescence endoscopy platform

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Demonstrate the feasibility of using the NIR-II endoscope and VEGF-A targeting fluorescent probe to image abnormal tissues of the gastrointestinal tract.

**Measure:** Validation of NIR-II endoscope and probe targeting VEGF-A

**Time Frame:** During endoscopy

### Eligibility Module

**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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** fulidan2021@ia.ac.cn

**Name:** Lidan Fu

**Phone:** 17754927702

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** fulidan2021@ia.ac.cn

- **Name:** Lidan Fu

- **Phone:** 17754927702

- **Role:** CONTACT

**Country:** China

**Facility:** Lidan Fu

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100190

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14011

- Name: Polyps

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M18681

- Name: Endothelial Growth Factors

- Relevance: LOW

- As Found: Unknown

- ID: M11900

- Name: Mitogens

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
