Abstract
Abstract Background) Sentinel lymph node (SLN) biopsy using indocyanine green fluorescence (fICG) method showed equal or better identification rate compared with blue dye or radioisotope (RI) method. In the fICG method, lymphatic vessels which drain into the SLNs can be seen through skin or subcutaneous tissue using near infrared camera (Photodynamic Eye®: PDE), and we can easily find the SLNs. However, whenever we observe the fluorescence images, we have to hold the PDE, turn off the operating light, and look at a monitor because fluorescence images cannot be seen directly. Medical imaging projection system (MIPS) is a new device which detects fluorescent emission from the organ and projects their images on the location of the fluorescence emission (Panasonic Connected Solutions Company, Japan). Projected images can be adjusted following the body movement or deformation of the organ. Therefore, MIPS could provide an option for real-time navigation for the SLN biopsy. The aim of this study was to evaluate the clinical utility of the MIPS. Patients and methods) Patients with clinically node-negative primary breast cancer underwent the fICG SLN biopsy using MIPS. Primary endpoint was identification rate of the fICG method using MIPS. At first, the study was conducted as an interventional study because the MIPS was the unapproved medical device. After approval of the MIPS, this study was conducted as an observational study. The study protocol was approved by the institutional review board at Kyoto University Hospital. All patients provided informed consent to participate in this study. Results) Between March 2016 and May 2017, 39 patients (40 procedures) underwent the fICG method SLN biopsy using MIPS. The median age was 55 years (range 32–74 years), and the median body mass index was 20.4 kg/m2 (range 17.7–27.7 kg/m2). About half had tumor stage T1 (58%) and 8 (20.0%) had DCIS. 8 procedures (20%) were performed after preoperative systemic therapy (PST). As MIPS itself can illuminate the operating field, SLN biopsy using MIPS was successfully performed without operating light in all procedures. At least one SLN was detected using MIPS for all procedures and the identification rate was 100% (95% CI: 91–100%). Median number of SLNs detected by MIPS was 3 (range 1–9) for all procedures, and 3 (range 2–8) for procedures after PST. Two pathologically positive SLNs and one SLN which included isolated tumor cells were detected by MIPS. In 25 procedures, RI was also used. 62 of 97 SLNs detected by MIPS (64%) were also detected by RI. However, no SLNs were detected only by RI. Conclusions) Although we still may not be able to avoid RI method because 25/40 (62.5%) procedures required the combined use of RI method, the fICG methods SLN biopsy using MIPS, which showed comparable identification rate of SLN with the conventional methods, could be useful tool with a view of allowing us to perform a real-time navigation surgery. Acknowledgements) This study was supported by Acceleration Transformative research for Medical innovation, Japan Agency for Medical Research and Development (AMED). Citation Format: Takada M, Takeuchi M, Suzuki E, Sato F, Matsumoto Y, Torii M, Sakita-Kawaguchi N, Nakayama Y, Okuda T, Nishino H, Seo S, Hatano E, Toi M. Real-time navigation for sentinel lymph node biopsy in breast cancer patients using projection mapping with indocyanine green fluorescence [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr PD2-07.
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