NCT05645523

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

Feasibility and Safety of Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 Objectives * 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. * To determine the percentage of patients with grade 3 or higher adverse events related to ICG use.

Detailed description

During surgery, participants will be given the dye to help the doctor see the lymph nodes to be removed. Pictures or a video of the procedure will be done. The number of lymph nodes removed will be recorded. After surgery, the lymph nodes will be examined. Participants will be followed for up to 24 hours after surgery to determine if there were any side effects from the dye.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Indocyanine Green	Given in to the vein (IV)

Timeline

• Start date: 2023-10-24
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-12-09
• Last updated: 2026-02-25

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study