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

NCT02910726 | Completed Phase 2 Results

• 1 other identifier: 16-1003
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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).

Conditions

Pediatric Patients With Solid Tumors

Keywords

indocyanine green fluorescent dye; Technetium lymphoscintigraphy; sentinel lymph node biopsy; 16-1003

Outcome Measures

Primary Outcomes (1)

• % 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

Study Arms (1)

Sentinel Lymph Node Biopsy

EXPERIMENTAL

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; Drug: indocyanine green (ICG)

Interventions

Sentinel Lymph Node Biopsy PROCEDURE

Sentinel Lymph Node Biopsy

indocyanine green (ICG) DRUG

Sentinel Lymph Node Biopsy

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (3)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

St. Jude's Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Sentinel Lymph Node Biopsy; Indocyanine Green

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Neeta Pandit-Taskar, MD
• Organization: Memorial Sloan Kettering Cancer Center

pandit-n@mskcc.org

1-833-MSK-KIDS

Study Officials

• Todd Heaton, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 22, 2016
• Study Start: September 13, 2016
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: October 5, 2022
• Results First Posted: October 5, 2022

Record last verified: 2022-09

Locations

US (3)