Abstract
BackgroundThe 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.MethodsSixty 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.ResultsBoth 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).ConclusionLFIS 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 RegistrationThis clinical trial was registered with the China Clinical Trial Center, registration number ChiCTR2000039542.
Highlights
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
The indocyanine green (ICG) method navigated by combined lymphatic fluorescence imaging system (LFIS) and methylene blue (MB) may be a promising alternative tracer for radioisotope in SLN mapping
Sixty female patients with early breast cancer and clinically confirmed negative axilla were recruited from the Department of Breast Surgery of the First Affiliated Hospital of Anhui Medical University of China Department of Tumor Surgery, The First Affiliated Hospital of Bengbu Medical College of China, Abbreviations: NIR system, near-infrared fluorescence imaging systems; SLNB, sentinel lymph node biopsy; MB, methylene blue; RI, Radioisotope; BMI, Body Mass Index; FNR, false negative rate; LAA, Langer’s axillary arch
Summary
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. Sentinel lymph node biopsy (SLNB) is the standard treatment for clinical axillary lymph node-negative breast cancer [1]. Clinical studies and meta-analysis showed that the exemption from axillary lymph node dissection for sentinel lymph node (SLN)negative patients does not affect their overall survival and saves them from its complications, such as upper limb lymphedema, numbness, and pain [2]. Radioisotope (RI) and blue dye are SLNB tracers that are globally used but have some limitations. Blue dye has a long learning curve, requires practice to achieve high accuracy, has the risk of anaphylactic reactions, and is widely used in China but has unsatisfactory detection rate. RI requires the assistance of nuclear medicine department, and its widespread use is limited by exposure to RIs and high preservation
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