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

RecruitingEARLY Phase 1Ages any - 20 YearsAllSt. Jude Children's Research Hospital
NCT05645523 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 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.
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What it tests

  • Indocyanine Green
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Where

3 sites
Lurie Children's Hospital
Chicago, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, United States
St. Jude Children's Research Hospital
Memphis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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