Fluorescence Surgery for Sentinel Node Identification in Melanoma

NCT02142244 | Unknown DMC

• 1 other identifier: BCHNIR01
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Lymph Node Metastasis

Keywords

Sentinel node biopsy; Near infra red light; Indocyanine green; micrometastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Specificity of the sentinel node biopsy

  60 months

Other Outcomes (3)

• Overall survival

  60 months

• Disease free survival

  60 months

• Specific cancer survival

  60 months

Study Arms (1)

Near infra red sentinel node biopsy

EXPERIMENTAL

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.

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

Interventions

Near infra red sentinel node biopsy PROCEDURE

Explicated in the protocol arm

Also known as: Sentinel node biopsy with fluorescence

Near infra red sentinel node biopsy

Indocyanine green DRUG

Explicated in the protocol arm

Near infra red sentinel node biopsy

Intraoperative Near-Infrared Imaging System DEVICE

Explicated in the protocol arm

Also known as: Photodynamic Eye (PDE), Pulsion, MiniFlare, The Flare Foundation

Near infra red sentinel node biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for sentinel node biopsy in standard care

You may not qualify if:

• 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

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

RECRUITING

Related Publications (4)

• 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.

  PMID: 17009138 BACKGROUND

• 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.

  PMID: 18711192 BACKGROUND

• 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.

  PMID: 21498148 BACKGROUND

• 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.

  PMID: 23078649 BACKGROUND

MeSH Terms

Conditions

Melanoma; Lymphatic Metastasis; Neoplasm Micrometastasis

Interventions

Sentinel Lymph Node Biopsy; Fluorescence; Indocyanine Green

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques; Luminescence; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vinicius L Vazquez, Ph.D.

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2021
• Last Updated: February 2, 2017

Record last verified: 2016-09

Locations

BR (1)