A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers

Study Overview
=================
Brief Summary
-----------------
This study is being done in patients that have tumors to find out how well sentinel lymph nodes (SLNs) can be found with a special dye called indocyanine green (ICG).

Official Title
-----------------
Non-inferiority Study of Intra-operative Indocyanine Green Fluorescent Dye Versus Technetium Lymphoscintigraphy for Sentinel Lymph Node Biopsy in Pediatric Malignancies

Conditions
-----------------
Pediatric Patients With Solid Tumors

Intervention / Treatment
-----------------
* Procedure: Sentinel Lymph Node Biopsy
* Drug: indocyanine green (ICG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients <30 years old with an extracoelomic solid tumor, diagnosis confirmed at the enrolling institution, requiring SLN biopsy Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Patients who are cleared for surgery Exclusion Criteria: History of reaction to ICG, iodides, or technetium radiocolloid Intracoelomic primary tumors or tumors expected to drain to an intracoelomic SLN Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage Patients unwilling or unable to sign informed consent Women who are pregnant or breast-feeding

Ages Eligible for Study
-----------------
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sentinel Lymph Node Biopsy<br>This is a single-center clinical trial to evaluate non-inferiority of ICG-guided SLN biopsy compared with the gold standard TcL-guided SLN biopsy in pediatric patients with solid tumors. Each patient will undergo TcL, consistent with the standard of care, but the surgeon will be blinded to the results preoperatively. Intraoperatively, ICG injection and transdermal lymphography will be used to identify the draining nodal basin and the position of the sentinel nodes. ICG transdermal lymphography will be considered successful if SLNs can be visualized on near-infrared imaging. After the transdermal lymphography results have been recorded, the surgeon will be unblinded to the TcL mapping. | Procedure: Sentinel Lymph Node Biopsy<br> <br> Drug: indocyanine green (ICG)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of Patients in Whom a Sentinel Lymph Node is Identified | These percentages will be compared using a non-inferiority comparison for matched pair data. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
indocyanine green fluorescent dye, Technetium lymphoscintigraphy, sentinel lymph node biopsy, 16-1003