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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Indocyanine Green


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indocyanine green (ICG)<br>Participants will receive Indocyanine green intraoperatively. | Drug: Indocyanine Green<br>* Given in to the vein (IV)<br>* Other names: ICG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful | The estimated percentage of ICG identification and its confidence interval (CI) based on the Pearson-Klopper method exact method will be calculated. | During surgery (Intraoperatively) | 
| Percentage of patients with grade 3 or more adverse events | Adverse Events will be captured from the time of ICG administration to 24 hours post-surgery. Adverse Events will be graded by this scale: the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | From the time of ICG administration to 24 hours after surgery (post-surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Indocyanine Green, Sentinel Lymph Node Mapping, Young Adult