Fluorescence Surgery for Sentinel Node Identification in Melanoma

Study Overview
=================
Brief Summary
-----------------
Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the standard procedure - a fluorescent contrast (indocyanine green) using special light (near infra-red) - looking for more precise diagnosis of the presence of the lymph node metastasis.

Detailed Description
-----------------
The main objectives of this study is perform a new technique added to the usual procedure for sentinel lymph node biopsy for cutaneous melanoma. The fluorescence surgery consists in a injection of indocyanine green around the primary tumor, or, when already excised (excisional biopsy), the biopsy site at the beginning of the surgery. Patient performs, in a standard fashion, the lymph scintigraphy prior the surgery and is injected at the same time a blue die similarly the indocyanine green. Immediately after the indocyanine infusion, the injection site is massaged and a near infra red light (NIR) is focused over it. An appropriated infra red camera is positioned over the lymphatic pathway, searching for the fluorescence and localizing the sentinel node at the basin. The skin is opened and the sentinel node is resected. The success or not in localizing the sentinel node is pointed and the standard techniques are applied - gamma probe and surgical location of a blue lymph node. All sentinel node characteristics are noted as number, which technic identified it, time, location. Later information will be gathered as histological status, surgical complications, recurrence and survival.

Official Title
-----------------
Infrared Fluorescence Guided Surgery for Sentinel Node Identification in Cutaneous Melanoma

Conditions
-----------------
Melanoma, Lymph Node Metastasis

Intervention / Treatment
-----------------
* Procedure: Near infra red sentinel node biopsy
* Drug: Indocyanine green
* Device: Intraoperative Near-Infrared Imaging System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for sentinel node biopsy in standard care Exclusion Criteria: Previous neoplasia Previous surgery or scar in the lymph node basin or primary tumor, except primary tumor biopsy Local recurrence Hypersensibility or allergy history to indocyanine or Iodine-based contrast media

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Near infra red sentinel node biopsy<br>Sentinel node biopsy adding indocyanine green injection at the tumor/biopsy site during the surgical procedure to the standard technique (blue die and lymph scintigraphy) and near infra red light for fluorescence. The indocyanine green saline solution - 5mg diluted in 10ml. will be injected in 4 points around the biopsy site - 4ml each - total 0.8mg - single procedure.Near infra red lens and camera will be used to detect the fluorescence and localize the sentinel node for biopsy. | Procedure: Near infra red sentinel node biopsy<br>* Explicated in the protocol arm<br>* Other names: Sentinel node biopsy with fluorescence;Drug: Indocyanine green<br>* Explicated in the protocol arm<br>Device: Intraoperative Near-Infrared Imaging System<br>* Explicated in the protocol arm<br>* Other names: The Flare Foundation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensibility of the sentinel node biopsy | The successful rate of the sentinel node localization and biopsy. The standard technique and the experimental one will be assessed | Time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of the sentinel node biopsy | The false negative sentinel node biopsy rate. The proportion of patients submitted to the procedure with histological negative biopsy, presenting lymph node metastasis at follow up. | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sentinel node biopsy, Near infra red light, Indocyanine green, micrometastasis