NCT06755554 Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer
| NCT ID | NCT06755554 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ukrainian Society of Clinical Oncology |
| Condition | Gastric Cancer Stage II |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 105 participants in total. It began in 2025-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to evaluate the safety and benefits of using indocyanine green in lymph node dissection for gastric cancer surgery. The primary endpoint is the average number of lymph nodes removed. Secondary study points are the average number of ICG-positive lymph nodes; the average number of metastatic ICG-positive lymph nodes; the number of postoperative complications and complications associated with the administration of ICG. Patients who meet the inclusion criteria for this study will be enrolled in the study after reviewing and signing an informed consent form. All patients will be included in one group and will receive surgical treatment in the amount of total or subtotal gastrectomy with lymphadenectomy D1, D1+, D2 or D2+. ICG is injected by the patient by endoscopic submucosal injection into 4 points around the tumor 24-12 hours before the start of the surgical intervention. Assessment of the number of fluorescent lymph nodes will be performed intraoperatively with their subsequent removal and mapping. The incidence of postoperative complications will be assessed by Clavien-Dindo.
Eligibility Criteria
Inclusion Criteria: * Tumor spread: cT2-4a cN0-3, * cM0; * Age: 18 - 80; * Gender: men and women; * ECOG: 0 - 1; * Histologic type of tumor: Adenocarcinoma of any subtype; * Degree of differentiation: G1 - G4; * Tumor localization: cardiac region, stomach floor, stomach body, antrum, pylorus, and pyloric region of the stomach; * Tumor spread: absence of tumor invasion into adjacent structures; * No history of cancer in the last 5 years; * No previous chemotherapy, surgery or radiation treatment for another cancer (except for neoadjuvant chemotherapy for gastric cancer); * Absence of severe comorbidity restricting laparoscopic approach. Exclusion Criteria: * M1 (distant metastases); * ECOG 2 - 4; * Age over 80 and under 18; * Presence of severe comorbidities, ASA\> 3; * Patient refusal to participate in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06755554 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Cancer Stage II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06755554 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 105 participants.
Is NCT06755554 currently recruiting?
Yes, NCT06755554 is actively recruiting participants. Contact the research team at oleksii.dobrzhanskyi@unci.org.ua for enrollment information.
Where is the NCT06755554 trial being conducted?
This trial is being conducted at Kyiv, Ukraine, Kyiv, Ukraine.
Who is sponsoring the NCT06755554 clinical trial?
NCT06755554 is sponsored by Ukrainian Society of Clinical Oncology. The trial plans to enroll 105 participants.
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