This phase II trial evaluates whether a diagnostic agent, indocyanine green (ICG), can be used with near-infrared imaging (NIR) during surgery to improve surgery to remove nearby lymph nodes (lymphadenectomy) in patients with gastric cancer. ICG is an imaging agent that glows (fluoresces) when used with NIR. Injecting ICG into tissue near the tumor may help surgeons better visualize the extent of the tumor and examine the surrounding lymph nodes.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04591028.
PRIMARY OBJECTIVES:
I. Assess the total number of lymph nodes removed after surgery and which are positive for ICG fluorescence.
II. Asses the rates in which ICG positive lymph nodes are also positive for disease.
III. Compare the variation in number of lymph nodes removed for each lymphatic station of gastrectomy with NIR + ICG versus (vs) gastrectomy without NIR + ICG.
OUTLINE:
Patients receive ICG via injection during endoscopy the day before standard of care surgery. On the day of surgery, patients undergo lymphadenectomy and gastrectomy with NIR.
After completion of study, patients are followed up for 12 weeks.
Lead OrganizationMayo Clinic in Florida
Principal InvestigatorEnrique Fernando Elli
