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Use of indocyanine green for detecting the sentinel lymph node in breast cancer patients: from preclinical evaluation to clinical validation.

ABSTRACT: Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. However, the existing methods, including methylene blue and nuclides, possess low efficiency and effectiveness in mapping SLNs, and to a certain extent exert side effects during application. Indocyanine green (ICG), as a fluorescent dye, has been proved reliable usage in SLN detection by several other groups. In this paper, we introduce a novel surgical navigation system to detect SLN with ICG. This system contains two charge-coupled devices (CCD) to simultaneously capture real-time color and fluorescent video images through two different bands. During surgery, surgeons only need to follow the fluorescence display. In addition, the system saves data automatically during surgery enabling surgeons to find the registration point easily according to image recognition algorithms. To test our system, 5 mice and 10 rabbits were used for the preclinical setting and 22 breast cancer patients were utilized for the clinical evaluation in our experiments. The detection rate was 100% and an average of 2.7 SLNs was found in 22 patients. Our results show that the usage of our surgical navigation system with ICG to detect SLNs in breast cancer patients is technically feasible.

SUBMITTER: Chi C

PROVIDER: S-EPMC3865279 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Use of indocyanine green for detecting the sentinel lymph node in breast cancer patients: from preclinical evaluation to clinical validation.

Chi Chongwei C Ye Jinzuo J Ding Haolong H He De D Huang Wenhe W Zhang Guo-Jun GJ Tian Jie J

PloS one 20131216 12

Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. However, the existing methods, including methylene blue and nuclides, possess low efficiency and effectiveness in mapping SLNs, and to a certain extent exert side effects during application. Indocyanine green (ICG), as a fluorescent dye, has been proved reliable usage in SLN detection by several other groups. In this paper, we introduce a novel surgical ...[more]

PMID: 24358319

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Project description:BackgroundThe breast cancer treatment paradigm has shifted to neoadjuvant treatment. There are many advantages to neoadjuvant treatment, such as tumor downsizing, in vivo tumor biology testing, treating micrometastasis, and achieving complete pathological response (a surrogate marker for overall survival). However, in the post neoadjuvant settings, sentinel lymph node biopsy can be done using a dual staining technique to decrease the false-negative rate (FNR) and increase the detection rate. However, many hospitals are not equipped to use radioisotopes. Here we investigate the detection rate and accuracy of sentinel lymph node biopsy in post neoadjuvant treatment breast cancer, comparing radioisotope, isosulfan blue, and indocyanine green (ICG) approaches.Material and methodsThis prospective study includes breast cancer patients (T2-4, N1-2) who had received neoadjuvant treatment. Carcinomas were confirmed by tissue pathology. Patients who had previous surgical biopsy or surgery involving the axillary regions, and those with a history of allergy to ICG, isosulfan blue, or radioisotope were excluded from the study.ResultThe study was done between July 1, 2019 to March 31, 2020. The mean age of participants was 53 years. Fourteen (60.87%) were post-menopause, two (8.7%) were perimenopause, and seven (30.43%) were premenopause. The clinical-stage distribution of the participants was: 2A (8.7%), 2B (34.78%), 3A (43.48%), and 3B (13.04%). The primary tumor size was 4.82 ± 2.73 cm. The lymph node size was 1.8 ± 0.96 cm. The detection rates at the individual level were 95.23% with ICG, 85.71% with isosulfan blue, and 85.71% with a radioisotope. The detection rate increased up to 100% when the ICG and blue dye methods were combined. The FNRs of sentinel lymph node biopsy at the individual level were: 10% using ICG, 30% using isosulfan blue, and 40% using radioisotope. At the lymph node level, the detection rates were 93.22% using ICG, 81.78% using isosulfan blue, and 53.87% using a radioisotope. The FNRs of sentinel lymph node biopsy at the lymph node level were 19.05% with ICG, 21.43% with isosulfan blue, and 18.03% with a radioisotope. However, the FNR was less than 10% when ICG, isosulfan blue, and a radioisotope were combined.ConclusionWe can perform sentinel lymph node biopsy by combining blue dye with ICG as an optional modality and achieve a comparable outcome with combine radioisotope in locally advanced breast cancer after neoadjuvant treatment.

Project description:BACKGROUND:Nodal staging is a major concern in colorectal cancer as it is an important prognostic factor. Several techniques that could potentially improve patient treatment and prognosis have been developed to increase the accuracy of nodal staging. Sentinel lymph node detection has been shown to accurately reflect nodal status in various tumors and has become the standard procedure in nodal staging of breast cancer and melanoma. However, in colorectal cancer, sentinel lymph node detection techniques are still controversial as the sensitivity reported in the literature varies from one study to another. Recently, indocyanine green fluorescence-guided surgery has been reported to be a useful technique for detection of macroscopic and microscopic metastatic deposits in lymph nodes after intravenous administration of indocyanine green dye. However, no studies have focused on the potential role of sentinel lymph node detection after systemic administration of indocyanine green dye, so-called systemic sentinel lymph nodes, or on the correspondence between the identification of the sentinel lymph node by standard local injection techniques and the detection of fluorescent lymph nodes with this new approach. OBJECTIVE:The aim of this protocol is to validate the concept of sentinel lymph nodes identified by fluorescence imaging after intravenous injection of indocyanine green dye and to compare the sentinel lymph nodes identified by fluorescence imaging with sentinel lymph nodes detected by the standard blue dye technique. METHODS:This study (SeLyNoFI; Sentinel Lymph Nodes Fluorescence Imaging) is a diagnostic, single-arm, open-label feasibility study, including patients with colorectal adenocarcinoma with or without metastatic disease who are admitted for elective colorectal resection of the primary tumor. This study evaluates the feasibility of a new approach for improving the accuracy of nodal staging using fluorescence imaging after intravenous administration of indocyanine green dye. Sensitivity, positive predictive value, and accuracy of the classical blue dye technique and of the investigatory fluorescence imaging technique will be calculated. Translational research will be proposed, if applicable. RESULTS:As of June 2020, this study has been registered. Submission for ethical review is planned for September 2020. CONCLUSIONS:The potential correlation between the two different approaches to detect sentinel lymph nodes offers new strategies for improving the accuracy of nodal staging in colorectal cancer. This new concept of the systemic sentinel lymph node and a greater understanding of the interactions between systemic sentinel lymph nodes and standard sentinel lymph nodes may provide important information regarding the underlying mechanism of primary tumor lymphatic drainage. The enhanced permeability and retention effect can also play a role in the fluorescence of systemic sentinel lymph nodes, especially if these lymph nodes are inflamed. In this case, we can even imagine that this new technique will highlight more instances of lymph node-positive colorectal cancer. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/17976.

Project description: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.

Dataset Information

Use of indocyanine green for detecting the sentinel lymph node in breast cancer patients: from preclinical evaluation to clinical validation.

Publications

Use of indocyanine green for detecting the sentinel lymph node in breast cancer patients: from preclinical evaluation to clinical validation.

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