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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-13

Study Completion Date

2022-09-02

Brief Summary

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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).

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Detailed Description

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Conditions

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Pediatric Patients With Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sentinel Lymph Node Biopsy

Intervention Type PROCEDURE

indocyanine green (ICG)

Intervention Type DRUG

Interventions

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Sentinel Lymph Node Biopsy

Intervention Type PROCEDURE

indocyanine green (ICG)

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No