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

Phase 2

Completed

• Conditions: Pediatric Patients With Solid Tumors
• Interventions: Procedure: Sentinel Lymph Node Biopsy; Drug: indocyanine green (ICG)

• Registration Number: NCT02910726
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-13
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Status Verified: 2022-09
• Primary Completion: 2022-09-02
• Study Completion: 2022-09-02
• Results First Submitted: 2022-09-07
• Results First Submitted QC: 2022-09-07
• Last Update Submitted: 2022-09-07
• Results First Posted: 2022-10-05
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel Lymph Node Biopsy	Sentinel Lymph Node Biopsy	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.
Sentinel Lymph Node Biopsy	indocyanine green (ICG)	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.

Primary Outcome Measures

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

Trial Locations

Locations (3)

St. Jude's Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States