Fluorescence Surgery for Sentinel Node Identification in Melanoma

Melanoma Clinical Trial

Official title:

Infrared Fluorescence Guided Surgery for Sentinel Node Identification in Cutaneous Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02142244
• Other study ID #: BCHNIR01
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2014
• Last updated: February 1, 2017
• Start date: May 2014
• Est. completion date: December 2021

Study information

• Verified date: September 2016
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: December 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymph Node Metastasis
• Melanoma

Intervention

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

Locations

Country	Name	City	State
Brazil	Barretos Cancer Hospital	Barretos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Frangioni JV. New technologies for human cancer imaging. J Clin Oncol. 2008 Aug 20;26(24):4012-21. doi: 10.1200/JCO.2007.14.3065. Review. — View Citation

Namikawa K, Yamazaki N. Sentinel lymph node biopsy guided by indocyanine green fluorescence for cutaneous melanoma. Eur J Dermatol. 2011 Mar-Apr;21(2):184-90. doi: 10.1684/ejd.2010.1237. — View Citation

Tanaka E, Choi HS, Fujii H, Bawendi MG, Frangioni JV. Image-guided oncologic surgery using invisible light: completed pre-clinical development for sentinel lymph node mapping. Ann Surg Oncol. 2006 Dec;13(12):1671-81. — View Citation

van der Vorst JR, Schaafsma BE, Verbeek FP, Swijnenburg RJ, Hutteman M, Liefers GJ, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Dose optimization for near-infrared fluorescence sentinel lymph node mapping in patients with melanoma. Br J Dermatol. 2013 Jan;168(1):93-8. doi: 10.1111/bjd.12059. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival		60 months
Other	Disease free survival	Presence and time to disease recurrence or not	60 months
Other	Specific cancer survival	Specific melanoma survival	60 months
Primary	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	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