Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to find out the usefulness and safety of a dye called Indocyanine Green (ICG for short). This dye will be used to help the surgeon find lymph nodes draining solid tumors inside the abdomen that need to be removed. This may also help the surgeon to find if the cancer has moved to other lymph nodes outside of the known area.

Primary Objective

• To determine the percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful at the time of retroperitoneal lymph node dissection for staging of visceral solid tumors. Also, to determine the percentage of patients with grade 3 or more adverse events.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital

Criteria

Inclusion Criteria:

• Any patient under the age of 21 years with visceral pediatric solid tumor requiring retroperitoneal lymph node dissection.

Exclusion Criteria:

• Subjects with a history of iodide allergies.

• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

• Pregnant female.

• Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.