Clinical trial NCT02142244: Fluorescence Surgery for Sentinel Node Identification in Melanoma
Official title: Infrared Fluorescence Guided Surgery for Sentinel Node Identification in Cutaneous Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Melanoma
Lymph Node Metastasis
Keywords: Sentinel node biopsy
Near infra red light
Indocyanine green
micrometastasis
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Sensibility of the sentinel node biopsy
timeFrame: Time of surgery
Secondary outcomes:
measure: Specificity of the sentinel node biopsy
timeFrame: 60 months
Other outcomes:
measure: Overall survival
timeFrame: 60 months
measure: Disease free survival
timeFrame: 60 months
measure: Specific cancer survival
timeFrame: 60 months
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: SP
Study officials:
affiliation: Barretos Cancer Hospital
name: Vinicius L Vazquez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1245/s10434-006-9194-6. Epub 2006 Sep 29.
citation: 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.
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.
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.