用于乳腺癌患者前哨淋巴结活检的吲哚菁绿荧光实时导航系统。
Real-Time Navigation System With Indocyanine Green Fluorescence for Sentinel Lymph Node Biopsy in Patients With Breast Cancer.
作者信息
Wang Zhaorui, Yang Xiaowei, Wang Jingjing, Liu Peng, Pan Yubo, Han Chunguang, Pei Jing
机构信息
Department of General Surgery, First Affiliated Hospital of Anhui Medical University, Hefei, China.
Department of Precision Machinery and Precision Instrumentation, University of Science and Technology of China, Hefei, China.
出版信息
Front Oncol. 2021 May 5;11:621914. doi: 10.3389/fonc.2021.621914. eCollection 2021.
BACKGROUND
The naked-eye invisibility of indocyanine green fluorescence limits the application of near-infrared fluorescence imaging (NIR) systems for real-time navigation during sentinel lymph node biopsy (SLNB) in patients with breast cancer undergoing surgery. This study aims to evaluate the effectiveness and safety of a novel NIR system in visualizing indocyanine green fluorescence images in the surgical field and the application value of combined methylene blue (MB) and the novel NIR system in SLNB.
METHODS
Sixty patients with clinical node-negative breast cancer received indocyanine green (ICG) and MB as tracers. Two NIR system instruments, namely, lymphatic fluorescence imaging system (LFIS) designed by the University of Science and Technology of China and vascular imager by Langfang Mingde Medical Biotechnology Co., Ltd. (Langfang vascular imager), were used as navigation assistance to locate sentinel lymph nodes (SLNs). Excising the lymph nodes developed by both MB and ICG by two NIR systems or palpably suspicious as SLNs and undergoing rapid pathological examination.
RESULTS
Both instruments exhibited 95% (57/60) success for real-time lymphatic fluorescent images. A total of 186 SLNs were identified, of which two were pathologically confirmed as lacking any lymph node tissue. SLN identification rate was 100% (184/184) for MB plus LFIS and 86.96% (160/184) for MB alone. The median number of SLNs identified by LFIS combined with MB was 3 (range of 1-8), which was significantly higher than that by MB alone at 2 (range 1-7) (P<0.05).
CONCLUSION
LFIS effectively detects SLNs in breast cancer, projects the fluorescence signals during surgery, and provides a continuous surgical navigation system without the need for a remote monitor. The ICG method navigated by combined LFIS and MB may be a promising alternative tracer for radioisotope in SLN mapping.
CLINICAL TRIAL REGISTRATION
This clinical trial was registered with the China Clinical Trial Center, registration number ChiCTR2000039542.
背景
吲哚菁绿荧光在肉眼下不可见，这限制了近红外荧光成像（NIR）系统在接受手术的乳腺癌患者前哨淋巴结活检（SLNB）期间进行实时导航的应用。本研究旨在评估一种新型NIR系统在可视化手术视野中吲哚菁绿荧光图像方面的有效性和安全性，以及亚甲蓝（MB）与新型NIR系统联合应用于前哨淋巴结活检的价值。
方法
60例临床淋巴结阴性乳腺癌患者接受吲哚菁绿（ICG）和MB作为示踪剂。使用两种NIR系统仪器，即中国科学技术大学设计的淋巴荧光成像系统（LFIS）和廊坊明德生物医药科技有限公司的血管成像仪（廊坊血管成像仪），作为导航辅助来定位前哨淋巴结（SLN）。通过两种NIR系统切除由MB和ICG共同显影或触诊可疑为SLN的淋巴结，并进行快速病理检查。
结果
两种仪器在实时淋巴荧光图像方面的成功率均为95%（57/60）。共识别出186个SLN，其中2个经病理证实没有任何淋巴结组织。MB联合LFIS的SLN识别率为100%（184/184），单独使用MB的识别率为86.96%（160/184）。LFIS联合MB识别出的SLN中位数为3个（范围1 - 8个），显著高于单独使用MB时的2个（范围1 - 7个）（P<0.05）。
结论
LFIS能有效检测乳腺癌中的SLN，在手术过程中投射荧光信号，并提供无需远程监测的连续手术导航系统。联合LFIS和MB的ICG方法可能是前哨淋巴结定位中放射性同位素的一种有前景的替代示踪剂。
临床试验注册
本临床试验在中国临床试验中心注册，注册号为ChiCTR2000039542。
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