Recruiting

ICGastrIndocyanine Green for Enhanced Lymph Node Dissection in Gastric Cancer Surgery

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What is being tested

Endoscopic injection of Indocyanine green

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorUkrainian Society of Clinical Oncology
Study ContactOleksii Dobrzhanskyi, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on improving the surgical treatment of gastric cancer by using a special dye called indocyanine green (ICG). The goal is to enhance the removal of lymph nodes, which are small glands that play a crucial role in the spread of cancer. Proper removal of these lymph nodes can significantly impact the survival and recovery of patients with gastric cancer. Traditionally, these surgeries are done without advanced imaging, but using ICG might help surgeons see and remove more lymph nodes, which is crucial for better treatment outcomes and preventing cancer recurrence. In this study, eligible patients with newly diagnosed stomach cancer will receive an injection of ICG dye around their tumor before undergoing surgery. This procedure helps identify which lymph nodes to remove more effectively. The trial will measure how many lymph nodes are removed using this method and assess any side effects or complications. The hope is that using ICG will increase the number of lymph nodes removed during surgery, leading to better management of the cancer and reducing the chances of it coming back. Participants will be closely monitored for any side effects from the dye or the surgery itself.

Official TitleInvestigation of Effect of Indocyanine Green on Volume of Lymph Node Dissection in Surgical Treatment of Gastric Cancer
Principal SponsorUkrainian Society of Clinical Oncology
Study ContactOleksii Dobrzhanskyi, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

105 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by SiteStomach DiseasesStomach Neoplasms

Criteria

12 inclusion criteria required to participate
Tumor spread: cT2-4a cN0-3,

cM0;

Age: 18 - 80;

Gender: men and women;

Show More Criteria

5 exclusion criteria prevent from participating
M1 (distant metastases);

ECOG 2 - 4;

Age over 80 and under 18;

Presence of severe comorbidities, ASA> 3;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Endoscopic injection of indocyanine green is performed under general anesthesia. Indocyanine green is injected into the submucosal layer of the stomach at 4 points around the tumor. The dosage for one administration is up to 5 mg. The total dosage for one patient for 4 doses is 20 mg. Monitoring of indocyanine green side effects occurs before the start of general anesthesia during radical surgery.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

National Cancer Institute

Kyiv, UkraineOpen National Cancer Institute in Google Maps
Recruiting soon

National Cancer Institute

Kyiv, Ukraine
Recruiting
2 Study Centers