Lymph node identification in skin malignancy using indocyanine green transcutaneously study

Abstract

Introduction:The incidence of malignant melanoma has been rising steadily over the past decades and Merkel cell carcinoma is a highly aggressive neuroendocrine skin tumor with a high mortality rate. Sentinel lymph node (SLN) biopsy is a recommended prognostic tool in primary cutaneous malignant melanomas of intermediate thickness and in all clinically node-negative Merkel cell carcinomas. The gold standard method for identification of SLNs is lymphoscintigraphy, which involves radioactive tracers. Indocyanine green-based near-infrared fluorescence imaging (NIRFI) has been also used for intraoperative SLN identification. We aim to evaluate the diagnostic sensitivity of the VisionSense VS3 NIRFI device for SNL identification. This device uses stereoscopic 3D high definition for both fluorescence and visible light imaging. Our hypothesis is that SLNs may be identified transcutaneously using fluorescent dye injections and NIRFI; therefore, obviating the need for lymphoscintigraphy in the future.Methods and analysis: lymph node identification in skin malignancy using indocyanine green transcutaneously is a prospective diagnostic sensitivity study conducted at the

Transcutaneous sentinel lymph node detection in cutaneous melanoma with indocyanine green and near-infrared fluorescence: A diagnostic sensitivity study

“…The protocol for this prospective diagnostic accuracy study to transcutaneously identify SLNs with ICG and NIRFI has been previously approved by the local Research Ethics Committees (BE 2016-01746) and published. [18] The trial registration number on ClinicalTrials.gov is NCT 03545334. The design of the study is in accordance with the STARD guidelines.…”

The Use and Technique of Sentinel Node Biopsy for Skin Cancer

“…Reported sensitivity and specificity of the procedure have ranged from 64 to 100 percent, with more recent studies citing both sensitivity and specificity above 90 percent. 4,9,10,27,30,35,36,40,111…”

“…Factors that guide this decision include presence of high-risk features such as young age, Clark level IV/V, lymphovascular invasion, positive deep biopsy margin close to the 0.8-mm cutoff, and mitotic rate greater than or equal to 1 mitosis/mm 2 . 10,11,50,51,53,55–58…”

“…Four small aliquots of 0.1 to 0.4 ml of 0.3 to 0.5 mCi radiotracer are injected intradermally surrounding the primary tumor site. 10,13,20,111,119 Dynamic images are then taken using a portable gamma camera for mapping of sentinel lymph nodes. During the sentinel lymph node biopsy, incision is made at the site of greatest radioactivity, detected intraoperatively by a handheld gamma probe.…”

“…Factors that guide this decision include presence of high-risk features such as young age, Clark level IV/V, lymphovascular invasion, positive deep biopsy margin close to the 0.8mm cutoff, and mitotic rate greater than or equal to 1 mitosis/mm 2 . 10,11,50,51,53,[55][56][57][58] For patients aged 55 years and older with melanoma between 0.3 and 2 mm in depth, DecisionDx-Melanoma (Castle Biosciences, Inc., Friendswood, Texas) is a gene expression profile test of 31 genes that stratifies melanoma patients by risk level and provides guidance on whether sentinel lymph node biopsy should be performed. Gene expression profile testing is currently performed on 5 to 10 percent of cases, and Medicare covers reimbursement of $7193 for sentinel lymph node biopsy-eligible patients.…”