RecruitingEarly Phase 1NCT05645523

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

Sponsor

St. Jude Children's Research Hospital

Enrollment

25 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

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.

Eligibility

Max Age: 20 Years

Inclusion Criteria1

Any patient under the age of 21 years with visceral pediatric solid tumor suspected to be Wilms tumor or para-testicular rhabdomyosarcoma requiring retroperitoneal lymph node dissection.

Exclusion Criteria4

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.

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