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Validation of a national prototype of detection of wide field fluorescence for sentinel lymph node localization in breast cancer

Grant number: 16/15191-4
Support type:Regular Research Grants
Duration: February 01, 2017 - June 30, 2019
Field of knowledge:Health Sciences - Medicine
Principal Investigator:José Luiz Barbosa Bevilacqua
Grantee:José Luiz Barbosa Bevilacqua
Home Institution: Hospital Sírio-Libanês. Sociedade Beneficente de Senhoras (SBSHSL). São Paulo , SP, Brazil
Assoc. researchers:Alfredo Carlos Simões Dornellas de Barros ; Angelo Biasi Govone ; Cristina Kurachi ; Jarbas Caiado de Castro Neto ; Katia Maciel Pincerato ; Paulo Luiz Aguirre Costa ; Ramon Gabriel Teixeira Rosa ; Vanderlei Salvador Bagnato

Abstract

Sentinel lymph node (SLNB) biopsy is the standard approach for staging the axilla in breast cancer. To identify and localize the SLN, the standard of care methods is radioactive tracer. The main disadvantage of the radioisotope method is its high implementation cost, particularly in health care facilities without the availability of a nuclear medicine department, and logistics to perform the radioactive injection, lymphoscintigraphy exam and surgery scheduling. Patent blue dye is another, but less efficient method of SLN mapping The disadvantages of patent blue are lower identification rates in relation to the radioactive tracer, the possibility of skin tattooing (sometimes permanently), and anaphylactic reactions of approximately 1%. A new technique of SLN mapping, termed as method ICG-fluorescence, in which it is used as a colorant indocyanine green (ICG) fluorescence associated with this substance when illuminated by infrared light beam with a spectrum located between 700 and 1400 nm, has been used with similar results as radioactive tracer and without the disadvantages of patent blue dye. The advantages of this technique are that ICG are: high SLN identification rates and false negative rates comparable to the radioisotope method; it is already employed in other medical situations and is available in Brazil; it is not a method which demands another medical team to inject the contrast, since injection is performed in real-time, by the surgeon himself during surgery; its implementation cost is low when compared to the radio-tracer method; ease of storage (vial lyophilized powder); it allows afferent lymphatic visualization of the axilla and of its path to the SLN, and can also be viewed prior to skin incision in most of the cases; it has a very low risk of anaphylaxis. The downside is that, likewise to the radioisotope method, it also requires a device for viewing the SLN. This equipment is not yet available for sale in Brazil and, abroad, it is expensive. The Photodynamic Eye (PDE®) has an approximate cost of sixty-eight thousand US dollars.ICV-fluorescence for SLN mapping is the method of choice in Japan for identification and SLN biopsy. There is vast literature on SLN mapping with ICV-fluorescence in breast cancer, showing its safety and efficacy and thus, confirming it is not experimental research. The ICV-Fluorescence method is not yet performed in Brazil. This project aims to implement this technology in our environment and the equipment validation with 100% national technology. Thus, the main potential benefits would be the generation of new technology to be made available to our society, transfer of technology, cost reduction and improving the LNS identification efficacy in breast cancer compared to patent blue. The ICG-fluorescence prototype, to be validated, has been already developed by Centro de Óptica e Fotônica do Instituto de Física de São Carlos (CePOF - programa CEPID FAPESP). (AU)