Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer
Recruiting
Phase 3
Interventional Study
Gastric Cancer Stage II
Gastric Cancer Stage III
Gastric Cancer
Gastrectomy for Gastric Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 105 (estimated)
- Sponsor
- Ukrainian Society of Clinical Oncology · Other
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About This Trial
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 associat…
Trial Locations
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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 p…
Contacts