Lymph Node Mapping in Patients With Endometrial Cancer

Study Overview
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Brief Summary
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This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.

Detailed Description
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PRIMARY OBJECTIVE: I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in endometrial cancer to predict nodal metastasis. SECONDARY OBJECTIVE: II. To examine 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. OUTLINE: Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard hysterectomy and salpingo-oophorectomy. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years for a total of 5 years according to the standard surveillance guidelines for endometrial cancer.

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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Procedure: sentinel lymph node detection
* Drug: indocyanine green solution
* Drug: isosulfan blue
* Procedure: sentinel lymph node biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 5-years 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, indocyanine green (ICG) or isosulfan blue (ISB) The patient has hepatic dysfunction confirmed by 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sentinel lymph node detection<br>Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy. | Procedure: sentinel lymph node detection<br>* Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue<br>Drug: indocyanine green solution<br>* Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue<br>* Other names: ICG solution;Drug: isosulfan blue<br>* Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue<br>* Other names: N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide;Procedure: sentinel lymph node biopsy<br>* Undergo sentinel lymph node biopsy<br>* Other names: sentinel node biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease | NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated. | average of 1-14 days after the procedure when final pathologic evaluation has been completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining | The percentage of metastatic cases analyzed by H&E will be compared to those of H&E-plus- IHC/ultrastaging using a z-test. | average of 1-14 days after the procedure when final pathologic evalulation has been completed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial Cancer, Robotic-Assisted Staging