NCT02142244

Fluorescence Surgery for Sentinel Node Identification in Melanoma

Infrared Fluorescence Guided Surgery for Sentinel Node Identification in Cutaneous Melanoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 318 (estimated)
• Sponsor: Barretos Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma
• Lymph Node Metastasis

Interventions

Type	Name	Description
PROCEDURE	Near infra red sentinel node biopsy	Explicated in the protocol arm
DRUG	Indocyanine green	Explicated in the protocol arm
DEVICE	Intraoperative Near-Infrared Imaging System	Explicated in the protocol arm

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-12-01
• Completion: 2021-12-01
• First posted: 2014-05-20
• Last updated: 2017-02-02

Locations

1 site across 1 country: Brazil