Fluorescence Surgery for Sentinel Node Identification in Melanoma

Barretos Cancer Hospital

Status: Unknown

Conditions: Melanoma; Lymph Node Metastasis

Treatments: Drug: Indocyanine green; Procedure: Near infra red sentinel node biopsy; Device: Intraoperative Near-Infrared Imaging System

Study type: Interventional

Funder types: Other

Identifiers

NCT02142244

BCHNIR01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 318 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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318 participants in 1 patient group

Near infra red sentinel node biopsy

Experimental group

Description:

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.

Treatment:

Device: Intraoperative Near-Infrared Imaging System

Drug: Indocyanine green

Procedure: Near infra red sentinel node biopsy