Lymph node identification in skin malignancy using indocyanine green transcutaneously study: Study protocol for a diagnostic accuracy study.

Lese, Ioana; Leckenby, Jonathan Ian; Taddeo, Adriano; Constantinescu, Mihai; Olariu, Radu (2019). Lymph node identification in skin malignancy using indocyanine green transcutaneously study: Study protocol for a diagnostic accuracy study. Medicine, 98(44), e17839. Wolters Kluwer 10.1097/MD.0000000000017839

[img]
Preview
Text
Lymph_node_identification_in_skin_malignancy_using.134.pdf - Published Version
Available under License Creative Commons: Attribution (CC-BY).

Download (250kB) | Preview

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 Department of Plastic and Hand Surgery at the University Hospital Berne, Inselspital, Switzerland. The study aims at recruiting 93 patients (start date September 2017) to compare the accuracy of VisionSense VS3 camera at identifying SLNs transcutaneously with the current gold standard, lymphoscintigraphy. Moreover, a secondary objective is to determine if anatomical location of the SLN and patient factors (eg, body mass index, age) have an impact on the ability of VisionSense to detect SLNs when compared with the same gold standard. TRIAL REGISTRATION NUMBER ClinicalTrials.gov NCT03545334.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Forschungsbereich Mu50 > Forschungsgruppe Handchirurgie
04 Faculty of Medicine > Department of Orthopaedic, Plastic and Hand Surgery (DOPH) > Clinic of Plastic and Hand Surgery > Plastic, Reconstructive and Aesthetic Surgery
04 Faculty of Medicine > Department of Orthopaedic, Plastic and Hand Surgery (DOPH) > Clinic of Plastic and Hand Surgery
04 Faculty of Medicine > Department of Orthopaedic, Plastic and Hand Surgery (DOPH) > Clinic of Plastic and Hand Surgery > Hand Surgery

UniBE Contributor:

Lese, Ioana; Leckenby, Jonathan Ian; Taddeo, Adriano; Constantinescu, Mihai Adrian and Olariu, Radu

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1536-5964

Publisher:

Wolters Kluwer

Language:

English

Submitter:

Veronika Picha

Date Deposited:

20 Nov 2019 14:39

Last Modified:

28 Nov 2019 16:11

Publisher DOI:

10.1097/MD.0000000000017839

PubMed ID:

31689874

BORIS DOI:

10.7892/boris.134885

URI:

https://boris.unibe.ch/id/eprint/134885

Actions (login required)

Edit item Edit item
Provide Feedback