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False Negative Rate: Spy-Elite assisted Sentinel Lymph Node Biopsy in Consecutive Cutaneous Melanoma Patients

Rafael A. Couto MD, Brenda Alleyne MD, Steven Rueda MD, Paul Duran MD, Brian Gastman, MD
Cleveland Clinic Foundation
2015-03-15

Presenter: Rafael A. Couto, MD

Affidavit:
The material submitted for presentation in this abstract has not been published in any scientific journal or previously presented at a major meeting. All the authors enlisted below contributed on this study.

Director Name: Steven Bernard, MD

Author Category: Resident Plastic Surgery
Presentation Category: Clinical
Abstract Category: General Reconstruction

Introduction

Despite the advances in the management of cutaneous melanoma, false negative sentinel lymph node biopsy (SNLB) rates are still reported in 5.2-22.0% of cases. Indocyanine green SPY-Elite navigation for SNLB is a novel technique shown to be effective in this population. The aim of this study is to determine the false negative rate of SNLB using indocyanine green SPY-Elite navigation.

Methods

Consecutive cutaneous melanoma patients who underwent radioisotope and indocyanine green SPY-Elite SNLB by the senior author (B.G.) between 2011-2013 were prospectively studied. Patient inclusion criteria were: 1) meeting the National Comprehensive Cancer Network criteria for SNLB and 2) having a negative SNLB report. The outcome variable was false negative SNLB (regional nodal recurrence in previously sampled negative SNL basin). Length of follow- up was date of surgery to the date of last follow-up/death. Predictive variables included: age, sex, Breslow thickness, mitotic index/mm2, TNM staging, and tumor and SNLB location.

Results

The study comprised of 80 subjects, 53.8% males and 46.3% females. Tumor locations were: trunk (36.3%), head/neck (26.3%), upper extremity (21.3%), and lower extremity (16.3%). Mean follow-up time was 19.3 (±8.6) months. Mean Breslow thickness and mitotic index/mm2 were 1.1 (±0.7) cm and 2.0 (±3.2), respectively. No false negative SNLB was observed in the cohort. Therefore, this technique exhibited a specificity and negative predictive value of 100%.

Conclusions

Indocyanine green SPY-Elite assisted SNLB exhibits high specificity and negative predictive value; it is an effective and reliable technique. This is an ongoing study with continuous patient enrollment.

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