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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02910726

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pediatric Patients With Solid Tumors	Procedure: Sentinel Lymph Node Biopsy Drug: indocyanine green (ICG)	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Sentinel Lymph Node Biopsy Drug: indocyanine green (ICG)

Arm

Intervention/Treatment

Experimental: 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.

Procedure: Sentinel Lymph Node Biopsy

Drug: indocyanine green (ICG)

Outcome Measures

Primary Outcome Measures

% 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
2	St. Jude's Children's Research Hospital	Memphis	Tennessee	United States	38105
3	Texas Children's Hospital	Houston	Texas	United States	77030