Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG

Study Overview
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Brief Summary
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The investigators hypothesis is that if sensitivity and specificity are found to be significantly higher than the current reports with Technesium-99 and ISB colorimetric dye, SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby limiting peri-operative morbidity. SLN biopsies might also improve the detection of metastatic disease, essentially lowering the recognized false-negative rate of standard lymphadenectomy analyzed by routine H&E pathologic analysis.

Detailed Description
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The study objective is to compare two sentinel lymph node detection technologies [fluorescence imaging and Indocyanine Green (ICG) dye verses standard laparoscopic colorimetric analysis using Isosulfan Blue (ISB) dye] for sensitivity and specificity of detecting metastatic disease in pelvic lymph nodes of women with endometrial cancer undergoing robotic-assisted laparoscopic hysterectomy and lymphadenectomy. The following three specific aims would be addressed in this research proposal: Specific Aim 1: To determine the ability of mapping bilaterally pelvic SLN in women with endometrial cancer undergoing robotic-assisted laparoscopic staging comparing two different methods (i.e., comparing the combination of colorimetric analysis-ISB dye + fluorescence imaging-ICG dye vs. colorimetric analysis-ISB dye alone). Specific Aim 2: To estimate the negative predictive value (NPV) of pelvic SLN in endometrial cancer with respect to predicting nodal metastasis. Specific Aim 3: To evaluate the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H&E) results.

Official Title
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Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue (ISB) and Indocyanine Green Dyes (ICG) With Fluorescence Imaging

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Device: ISB dye and standard white light imaging
* Device: ICG dye and FireFly fluorescence imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be ≥18 and ≤85 years of age. The patient must be female. The patient must be willing and able to provide informed consent. The patient is willing and able to comply with the study protocol. The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy. The patient agrees to follow-up examinations out to 6-weeks post-treatment Exclusion Criteria: The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy. The patient has known or suspected allergies to iodine, ICG or ISB. The patient has hepatic dysfunction confirmed by elevated liver function studies (i.e., hepatic enzyme SGOT, SGPT or Bilirubin > 2 x normal (based on reference values from the laboratory used by the patient)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ISB dye, standard white light<br>SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging. | Device: ISB dye and standard white light imaging<br>* Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.<br>* Other names: Isosulfan Blue dye;|
| Experimental: ICG dye, FireFly fluorescence imaging<br>SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging. | Device: ISB dye and standard white light imaging<br>* Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.<br>* Other names: Isosulfan Blue dye;Device: ICG dye and FireFly fluorescence imaging<br>* Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.<br>* Other names: Indocyanine green dye;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes. |  | through 6 weeks post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis. | The standard definition for negative predictive value was used to calculate NPV. There was one false negative SLN in this study, 39 true positive sentinel lymph nodes, and 140 negative pelvic metastatic patients. NPV = 140/141=99.3% | through 6 weeks post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLN, da Vinci, Sentinel lymph nodes, Firefly, Sentinel lymph node mapping, Fluorescence Imaging, SLN mapping