scholarly journals Systemic Sentinel Lymph Node Detection Using Fluorescence Imaging After Indocyanine Green Intravenous Injection in Colorectal Cancer: Protocol for a Feasibility Study

10.2196/17976 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e17976 ◽  
Author(s):  
Gabriel Liberale ◽  
Sophie Vankerckhove ◽  
Fikri Bouazza ◽  
Maria Gomez Galdon ◽  
Denis Larsimont ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Lymph Nodes ◽  
Indocyanine Green ◽  
Fluorescence Imaging ◽  
Sentinel Lymph Nodes ◽  
Nodal Staging ◽  
Sentinel Lymph Node Detection ◽  
Indocyanine Green Dye

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

scholarly journals Systemic Sentinel Lymph Node Detection Using Fluorescence Imaging After Indocyanine Green Intravenous Injection in Colorectal Cancer: Protocol for a Feasibility Study (Preprint)

2020 ◽  
Author(s):  
Gabriel Liberale ◽  
Sophie Vankerckhove ◽  
Fikri Bouazza ◽  
Maria Gomez Galdon ◽  
Denis Larsimont ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Lymph Nodes ◽  
Indocyanine Green ◽  
Fluorescence Imaging ◽  
Sentinel Lymph Nodes ◽  
Nodal Staging ◽  
Sentinel Lymph Node Detection ◽  
Indocyanine Green Dye

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 PRR1-10.2196/17976

scholarly journals ICG/NIR TECHNIQUE IN LYMPH NODE MAPPING IN PATIENTS WITH COLORECTAL CANCER

2021 ◽  
pp. 97-102
Author(s):  
S. V. Maliborska ◽  
V. V. Holotiuk ◽  
Y. D. Partykevych
Keyword(s):  
Colorectal Cancer ◽  
Rectal Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Lymph Nodes ◽  
Indocyanine Green ◽  
Treatment Strategy ◽  
Near Infrared ◽  
Sentinel Lymph Nodes ◽  
Optimal Treatment Strategy

Most cancers in humans are epithelial in nature and such neoplasms metastasize via lymphatics; therefore, the lymphatic system plays a pivotal role in a significant number of malignancies. The hematologic behavior of metastatic cancer has been extensively studied, but little is known regarding lymphatic metastasis. Sentinel lymph node (SLN) is the first node to receive the drainage directly from a tumor. Detection and pathological examination of the SLN is an important oncological procedure that minimizes morbidity related to extensive nodal dissection. After many years of observation and research on its use in various malignancies SLN biopsy has become the standard surgical treatment in patients with malignant melanoma, breast and cervical cancers. Today, the issue of diagnosing lymphogenous metastasis in patients with colorectal cancer remains relevant. Standardized methods for examining lymph nodes do not allow to reliably establish the presence of their metastatic lesions. For a more effective assessment, additional examinations are carried out to identify the sentinel lymph node and its precision study, in particular, one of the newest methods is mapping of sentinel lymph nodes using Indocyanine Green (ICG) using near infrared radiation (NIR). Along with the introduction of new technologies, such as the fluorescent dyes indocyanine green (ICG) and near-infrared fluorescence (NIR), and pathologic ultrastaging, Indocyanine green fluorescence-imaging (ICG-FI) has emerged as a potential tool for increasing the accuracy of staging of patients with primary colorectal cancer (CRC) through the detection of sentinel lymph nodes (SLNs). Indocyanine green (ICG) is an inexpensive and safe non-specific fluorescent probe. SLN detection rate has increased and false-negative rate has decreased.Colorectal cancer is the third most common cancer in the Western hemisphere and the incidence increases with increasing age. Surgery is the only curative therapy for localized colorectal cancer and adjuvant chemotherapy is usually recommended for patients with lymph node metastases. Surgery, radiation therapy and chemotherapy are the key components of rectal cancer therapy. Local recurrence greatly affects the treatment efficiency and the survival outcomes for patients with rectal cancer. Lateral pelvic lymph node (LPLN) metastasis (LPNM) is an important factor for local recurrence. Accurate staging TNM of colorectal cancer is essential for evaluating the prognosis and developing an optimal treatment strategy. The presence of metastatic lateral pelvic lymph nodes has been shown to portend a worse prognosis for patients with low rectal cancer. SLN biopsy should be used in this patients for evaluating the prognosis and developing an optimal treatment strategy. Only with all of the above diagnostic tools can accurate diagnosis according to TNM and the choice of the right treatment strategy. The article analyzes and summarizes the scientific literature data on the methods for determining the sentinel lymph node. The sensitivity and specificity of the sentinel lymph node detection using ICG/NIR has been demonstrated. The analysis of various techniques for introducing indocyanine green, the rate of SLN identification was carried out.

Adipose-only sentinel lymph nodes: a finding during the adaptation of a sentinel lymph node mapping algorithm with indocyanine green in women with endometrial cancer

2019 ◽  
Vol 29 (1) ◽  
pp. 53-59
Author(s):  
J A Harold ◽  
D Uyar ◽  
J S Rader ◽  
E Bishop ◽  
M Nugent ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Lymph Nodes ◽  
Indocyanine Green ◽  
Sentinel Lymph Node Mapping ◽  
Sentinel Lymph Nodes ◽  
Lymph Node Mapping ◽  
Sentinel Lymph Node Identification ◽  
Surgeon Experience

ObjectiveTo identify factors that affect successful adaptation of sentinel lymph node mapping and those that lead to unintended adipose-only sentinel lymph node identification.MethodsSurgical and pathological data were prospectively collected on patients with endometrial cancer who underwent sentinel lymph node mapping with indocyanine green with or without pelvic and/or para-aortic lymph node dissection between November 2013 and April 2017. All mapping cases were performed with the robotic system. Adipose-only specimens were defined as a sentinel lymph node without a pathologically identified lymph node after ultrastaging.ResultsA total of 202 patients were included: 83% had endometrioid pathology, 12% serous, 3% carcinosarcoma, and 2% clear cell, with mixed pathology noted in 2%. The bilateral sentinel lymph node detection rate was 66%, and the rate of mapping at least a unilateral sentinel lymph node was 86%. Neither the bilateral nor the unilateral sentinel lymph node mapping rate changed with increased surgeon experience. The rate of adipose-only sentinel lymph node identification was more frequent when comparing the first 10 cases (37%), cases 11 – 30 (28%), and > 30 cases (9%) (P = 0.006). Body mass index > 30 kg/m2, uterine fibroids, The International Federation of Gynecology and Obstetrics (FIGO) grade, and histology were not found to have a statistically significant impact on either sentinel lymph node identification or adipose-only sentinel lymph node identification. Adipose-only sentinel lymph nodes were more likely with increased time from cervical injection to identification of the sentinel lymph node in the right hemipelvis. The median range was 28 min (14–73) for true sentinel lymph node identification vs 33 min (23–74) for adipose-only sentinel lymph node identification (P = 0.02).ConclusionPatient and surgeon factors did not impact the identification of sentinel lymph nodes over time. Adipose-only sentinel lymph nodes were more frequently identified in the initial cases and represent a potential complication to adapting sentinel lymph node biopsy without lymphadenectomy. The increase in adipose-only sentinel lymph node identification that was associated with time from cervical injection may represent delayed or disrupted uptake of indocyanine green.

Sentinel-node biopsy in early stage ovarian cancer: a prospective multicentre study (SELLY)

2019 ◽  
Vol 29 (9) ◽  
pp. 1437-1439
Author(s):  
Giovanni Scambia ◽  
Camilla Nero ◽  
Stefano Uccella ◽  
Enrico Vizza ◽  
Fabio Ghezzi ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Lymph Nodes ◽  
Indocyanine Green ◽  
Epithelial Ovarian Cancer ◽  
Sample Size ◽  
Early Stage ◽  
Sentinel Lymph Nodes ◽  
Exclusion Criteria

BackgroundSystematic para-aortic and bilateral pelvic lymphadenectomy is included in the standard comprehensive surgical staging in presumed early epithelial ovarian cancer. No prospective randomized evidence suggests it has potential therapeutic value, and related morbidity is not negligible.Primary Objective(s)To assess sensitivity, safety, and feasibility of the sentinel lymph node technique in identifying the presence of lymph node metastases in patients with early stage epithelial ovarian cancer.Study HypothesisSentinel lymph node detection with indocyanine green can accurately predict nodal status in a cohort of women with early stage epithelial ovarian cancer.Trial DesignThe SELLY trial is a prospective phase II interventional multicenter study.Major Inclusion/Exclusion CriteriaInclusion criteria: Eastern Cooperative Oncology Group 0–1, apparent International Federation of Gynecology and Obstetrics (FIGO) stage I-II, histologically proven epithelial ovarian cancer.Exclusion criteria: evidence of carcinomatosis, mucinous only at definitive histology.Endpoint(s)Primary endpoint is sensitivity (true positive rate). Secondary endpoints include safety (complications rate of the procedure) and feasibility.Sample SizeAssuming a sensitivity of 98.5% in predicting positive sentinel lymph nodes at histology, a pathological lymph node prevalence of 14.2%, a precision of estimate (ie, the maximum marginal error) d=5%, and a type I error α=0.05, a sample size of 160 patients is needed to test the general hypothesis (ie, to answer whether sentinel lymph nodes identified with indocyanine green can accurately predict nodal status at histology of patients with apparently early epithelial ovarian cancer). Assuming a drop-out rate of 10%, a total of 176 patients will be enrolled in the study.Estimated Dates for Completing Accrual and Presenting ResultsThe accrual should be completed by December 2020 and results should be presented by March 2021.Trial RegistrationThe trial is registered at clinicaltrials.gov (NCT03563781).

scholarly journals Sentinel Lymph Nodes Mapping in Cervical Cancer a Comprehensive Review

2016 ◽  
Vol 27 (1) ◽  
pp. 154-158 ◽  
Author(s):  
Yasser Diab
Keyword(s):  
Cervical Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Lymph Nodes ◽  
Indocyanine Green ◽  
High Sensitivity ◽  
Sentinel Lymph Node Mapping ◽  
Sentinel Lymph Nodes ◽  
Detection Rates ◽  
Lymph Node Mapping

ObjectiveA comprehensive literature search for more recent studies pertaining to sentinel lymph node mapping in the surveillance of cervical cancer to assess if sentinel lymph node mapping has sensitivity and specificity for evaluation of the disease; assessment of posttreatment response and disease recurrence in cervical cancer.Materials and MethodsThe literature review has been constructed on a step wise study design that includes 5 major steps. This includes search for relevant publications in various available databases, application of inclusion and exclusion criteria for the selection of relevant publications, assessment of quality of the studies included, extraction of the relevant data and coherent synthesis of the data.ResultsThe search yielded numerous studies pertaining to sentinel lymph node mapping, especially on the recent trends, comparison between various modalities and evaluation of the technique. Evaluation studies have appraised high sensitivity, high negative predictive values and low false-negative rate for metastasis detection using sentinel lymph node mapping. Comparative studies have established that of all the modalities for sentinel lymph node mapping, indocyanine green sentinel lymph node mapping has higher overall and bilateral detection rates. Corroboration of the deductions of these studies further establishes that the sentinel node detection rate and sensitivity are strongly correlated to the method or technique of mapping and the history of preoperative neoadjuvant chemotherapy.ConclusionsThe review takes us to the strong conclusion that sentinel lymph node mapping is an ideal technique for detection of sentinel lymph nodes in cervical cancer patients with excellent detection rates and high sensitivity. The review also takes us to the supposition that a routine clinical evaluation of sentinel lymph nodes is feasible and a real-time florescence mapping with indocyanine green dye gives better statistically significant overall and bilateral detection than methylene blue.

scholarly journals Sentinel Lymph Node Detection by Blue Dye Versus Indocyanine Green Fluorescence Imaging in Colon Cancer

2016 ◽  
Vol 36 (9) ◽  
pp. 4853-4858 ◽  
Author(s):  
GABRIEL LIBERALE ◽  
SOPHIE VANKERCKHOVE ◽  
MARIA GOMEZ GALDON ◽  
DENIS LARSIMONT ◽  
BISSAN AHMED ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Indocyanine Green ◽  
Fluorescence Imaging ◽  
Blue Dye ◽  
Sentinel Lymph Node Detection ◽  
Green Fluorescence ◽  
Indocyanine Green Fluorescence ◽  
Indocyanine Green Fluorescence Imaging

scholarly journals Sentinel Lymph Node Detection Using Laser-Assisted Indocyanine Green Dye Lymphangiography in Patients with Melanoma

2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Vikalp Jain ◽  
Brett T. Phillips ◽  
Nicole Conkling ◽  
Colette Pameijer
Keyword(s):  
Methylene Blue ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Indocyanine Green ◽  
Blue Dye ◽  
Sentinel Lymph Node Detection ◽  
Indocyanine Green Dye ◽  
Vital Component ◽  
A New Technique ◽  
Dermal Injection

Introduction. Sentinel lymph node (SLN) biopsy is a vital component of staging and management of multiple cancers. The current gold standard utilizes technetium 99 (tech99) and a blue dye to detect regional nodes. While the success rate is typically over 90%, these two methods can be inconclusive or inconvenient for both patient and surgeon. We evaluated a new technique using laser-assisted ICG dye lymphangiography to identify SLN.Methods. In this retrospective analysis, we identified patients with melanoma who were candidates for SLN biopsy. In addition to tech99 and methylene blue, patients received a dermal injection of indocyanine green (ICG). The infrared signal was detected with the SPY machine (Novadaq), and nodes positive by any method were excised.Results. A total of 15 patients were evaluated, with 40 SLNs removed. Four patients were found to have nodal metastases on final pathology. 100% of these 4 nodes were identified by ICG, while only 75% (3/4) were positive for tech99 and/or methylene blue. Furthermore, none of the nodes missed by ICG (4/40) had malignant cells.Conclusion. ICG dye lymphangiography is a reasonable alternative for locating SLNs in patients with melanoma. Prospective studies are needed to better ascertain the full functionality of this technique.

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