Gastrointestinal CarcinomaPhase 1NCT06430372
Study of VEGF-A Targeting NIR-II Fluorescence Endoscopy in the Gastrointestinal Tract
A Phase 1 study testing Bev-ICG and NIR-II fluorescence endoscopy platform in people with Gastrointestinal Carcinoma and Dysplasia, run by Institute of Automation, Chinese Academy of Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Carcinoma, Dysplasia, Gastrointestinal Polyp
- What is being tested?
- Bev-ICG and NIR-II fluorescence endoscopy platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to 30 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Lidan Fu
Beijing, Beijing Municipality, 100190
Lidan Fu, 17754927702, fulidan2021@ia.ac.cn
About this study
Official title: Study of Vascular Endothelial Growth Factor A Targeting NIR-II Fluorescence in the Endoscopy of 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:
- To translate the NIR-II approach into the endoscopy, and understand its advantages and limitations on detecting abnormal tissues in gastrointestinal.
- To validate whether topical administration of a targeting probe can stick to abnormal tissues and be detected by the NIR-II endoscope.
- To validate the safety and effectiveness of the topical administration of VEGF-A targeting probes for clinical application.
- Being tested
- Bev-ICG, NIR-II fluorescence endoscopy platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bev-ICGDrug
Probe targeting VEGF-A that is topically administrated during the endoscopy
NIR-II fluorescence endoscopy platformDevice
An endoscopic detection device which can detect and visualize NIR-II fluorescent signal during the endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Bev-ICG NIR-II Endoscopy | Experimental | The patients will receive a topical administration of probe (Bev-ICG) during the endoscopy. Then fluorescence imaging will be performed to guide the detection. Receives: Drug: Bev-ICG; Device: NIR-II fluorescence endoscopy platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start20 Jul 2023
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Automation, Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenhua Hu, Institute of Automation, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430372
- Sponsor's protocol ID
- NIR-II-ENDO
- Status last verified
- May 2025
- First submitted
- 21 May 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Vascular Endothelial Growth Factor A Targeting NIR-II Fluorescence in the Endoscopy of Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT06430372
- Acronym / sponsor ID
- NIR-II-ENDO
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Automation, Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To translate the NIR-II approach into the endoscopy, and understand its advantages and limitations on detecting abnormal tissues in gastrointestinal.
- To validate whether topical administration of a targeting probe can stick to abnormal tissues and be detected by the NIR-II endoscope.
- To validate the safety and effectiveness of the topical administration of VEGF-A targeting probes for clinical application.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bev-ICG NIR-II Endoscopy | Experimental | Drug: Bev-ICG, Device: NIR-II fluorescence endoscopy platformThe patients will receive a topical administration of probe (Bev-ICG) during the endoscopy. Then fluorescence imaging will be performed to guide the detection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bev-ICGProbe targeting VEGF-A that is topically administrated during the endoscopy | Drug | Bev-ICG NIR-II Endoscopy |
| NIR-II fluorescence endoscopy platformAn endoscopic detection device which can detect and visualize NIR-II fluorescent signal during the endoscopy | Device | Bev-ICG NIR-II Endoscopy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bev-ICG and NIR-II fluorescence endoscopy platform in people with Gastrointestinal Carcinoma and Dysplasia, run by Institute of Automation, Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lidan Fu (17754927702, fulidan2021@ia.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of NIR-II endoscope and probe targeting VEGF-A (time frame: During endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.