Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery

Study Overview
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Brief Summary
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This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine the detection rate, sensitivity, and negative predictive value of sentinel lymph node (SLN) biopsy in endometrial cancer patients. SECONDARY OBJECTIVES: I. To compare different surgical modalities (open procedures, minimally invasive procedures, and single-site technology) and different injectants (isosulfan blue and indocyanine green) for SLN biopsy. II. To determine total operating room time (from the time the patient enters the room to the time the patient leaves the room) as well as console time (robotic)/operating time for minimally invasive procedures. OUTLINE: Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. After completion of study treatment, patients are followed up at 2-4 weeks.

Official Title
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Sentinel Lymph Node Mapping for Endometrial Cancer

Conditions
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Stage I Endometrial Carcinoma, Stage II Endometrial Carcinoma, Stage III Endometrial Carcinoma, Stage IV Endometrial Carcinoma

Intervention / Treatment
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* Procedure: lymph node mapping
* Procedure: sentinel lymph node biopsy
* Drug: isosulfan blue
* Drug: indocyanine green solution
* Procedure: therapeutic conventional surgery
* Procedure: lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer Women should have received no prior therapy for their disease Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer Women must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Women who are receiving any other investigational agents Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue or indocyanine green or other agents used in this study Women with hypersensitivity to phenylmethane compounds, or a history of allergic reaction to iodides Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease) Women with a history of a prior malignancy Women may also be excluded at the discretion of their surgeon if he or she feels that the patient is not an appropriate candidate
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: Diagnostic (SLN mapping, biopsy, surgery)<br>Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. | Procedure: lymph node mapping<br>* Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution<br>Procedure: sentinel lymph node biopsy<br>* Undergo SLN biopsy<br>* Other names: sentinel node biopsy;Drug: isosulfan blue<br>* Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution<br>* Other names: N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide;Drug: indocyanine green solution<br>* Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution<br>* Other names: ICG solution;Procedure: therapeutic conventional surgery<br>* Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy<br>Procedure: lymphadenectomy<br>* Undergo para-aortic lymphadenectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Sentential Lymph Node (SLN) Biopsy | Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node. | Up to 4 weeks | 
| Number of Participants in Whom a SLN is Detected | Detection Rate as defined by number of participants in whom a SLN is detected | Up to 4 weeks | 
| Percent of Hemipelvises Identified With SLN | Detection rate, as defined by percent of hemipelvises identified with SLN | Up to 4 weeks | 
| Number of Participants With Sentinel Nodes Per Side of Pelvis | Detection rate, as defined as number of participants with a sentinel node found per side of pelvis | Up to 4 weeks | 
| False Negative Rate as Defined as Proportion of Participants With False Negative Detection | False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node | Up to 4 weeks | 
| Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology) | The percent of true positive SLN identified with surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation. | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution | Percent of true positive SLN identified will be compared between injectants utilized using a two sample test of proportions based on a normal approximation. Comparisons will be performed using two sample tests of proportions based on a normal approximation. | Up to 4 weeks | 
| Total Operating Room Time in Minutes | Total operating room time will be estimated as a mean with 95% confidence interval if the data have an approximately normal distribution. Otherwise, the median and a bootstrapped 95% confidence interval for the median will be reported. Similar summaries will be provided for the console time (robotic)/ operating time. | From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks |