This phase I trial studies the side effects of indocyanine green (ICG) and how well it works to guide the identification of lymph nodes that may be the first to contain tumor cells (sentinel lymph node mapping) in pediatric solid tumor patients undergoing lymph node removal (dissection). Whether a solid tumor has spread from where it first started (primary site) to the lymph nodes (lymph node metastasis) is the most important predictive factor in pediatric solid tumors, and if it is under-diagnosed, treatment may not be tailored appropriately, and survival may be negatively affected. ICG is a special dye that glows green when exposed to near infra-red light. ICG is injected around the tumor site and travels from the tumor and drains into the main lymph node. This serves as a marker and helps to identify the lymph nodes that may be first exposed to tumor cells as well as small areas of lymph node metastasis. This may be a safe and effective way to guide sentinel lymph node mapping in pediatric solid tumor patients undergoing lymph node dissection.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07054944.
Locations matching your search criteria
United States
New York
Rochester
University of RochesterStatus: Approved
Contact: Abdelhafeez Hassan Abdelhafeez
Phone: 585-275-4435
PRIMARY OBJECTIVES:
I. To determine the percentage of patients in whom indocyanine green (ICG)-guided lymph node mapping was successful at the time of lymph node sampling for staging of solid tumors.
II. To determine the percentage of patients with adverse events related to ICG use.
EXPLORATORY OBJECTIVES:
I. To assess the accuracy (true-positive rate and true-negative rate) of indocyanine green (ICG)-guide sentinel lymph node (SLN) biopsy in patients with pediatric solid tumor who require lymph node sampling.
II. To determine the percentage of participants with sentinel lymph node (SLN) found in an unanticipated region outside the standard of care lymph nodes sampling basin.
OUTLINE:
Patients receive ICG via peri-tumoral or lymphatic injection and undergo near-infrared fluorescence imaging for sentinel lymph node mapping and sample collection during standard of care lymph node dissection.
After completion of study intervention, patients are followed for up to 24 hours post-surgery.
Lead OrganizationUniversity of Rochester
Principal InvestigatorAbdelhafeez Hassan Abdelhafeez
