Fluorescence Surgery for Sentinel Node Identification in Melanoma

Not Applicable

• Conditions: Melanoma; Lymph Node Metastasis
• Interventions: Procedure: Near infra red sentinel node biopsy; Drug: Indocyanine green; Device: Intraoperative Near-Infrared Imaging System

• Registration Number: NCT02142244
• Lead Sponsor: Barretos Cancer Hospital

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-20
• Status Verified: 2016-09
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02
• Primary Completion: 2018-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 318

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Near infra red sentinel node biopsy	Near infra red sentinel node biopsy	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.
Near infra red sentinel node biopsy	Intraoperative Near-Infrared Imaging System	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.
Near infra red sentinel node biopsy	Indocyanine green	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.

Primary Outcome Measures

Name	Time	Method
Sensibility of the sentinel node biopsy	Time of surgery	The successful rate of the sentinel node localization and biopsy. The standard technique and the experimental one will be assessed

Secondary Outcome Measures

Name	Time	Method
Specificity of the sentinel node biopsy	60 months	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.

Trial Locations

Locations (1)

Barretos Cancer Hospital; 🇧🇷 Barretos, SP, Brazil