Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer

Study Overview
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Brief Summary
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Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG, sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor, will be identified. SLNs will be surgically removed and provided to Pathology for evaluation. Non-sentinel nodes will also be surgically removed, as is consistent with routine medical care for these patients, and given to Pathology for evaluation. A positive SLN may be the most accurate identifier of the extra-uterine spread of disease, and will provide information about the extent of surgical node removal necessary.

Official Title
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The Feasibility and Benefits of Using Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer

Conditions
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Endometrial Cancer, Sentinel Lymph Node Detection

Intervention / Treatment
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* Procedure: ICG Dye


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult women patients (>18 years of age and <90 years of age) Research authorization (consent) Pre-operative diagnosis of clinical Stage 1 endometrial cancer Pre-operative indications of grade 3 tumor, and/or tumor size greater than 2 cm in size Scheduled and consented to undergo robotic hysterectomy and surgical staging, including bilateral pelvic and para-aortic lymphadenectomy Exclusion Criteria: Severe coagulopathy or severe thrombocytopenia Severe anemia Severe cardio-pulmonary comorbidities demanding minimization of operative time History of liver disease Iodide allergy Emergent operation Additional surgical risk as determined during surgery at the discretion of the attending Impaired capacity to make informed medical decisions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: ICG Dye<br>Patients received injections of Indocyanine green (ICG) for sentinel lymph node (SLN) visualization using near-infrared (NIR) imaging. | Procedure: ICG Dye<br>* ICG Dye injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of sentinel lymph node(s) | The primary outcome is to determine whether sentinel lymph nodes (SLN) were accurately visualized using Indocyanine green (ICG) and near-infrared (NIR) imaging. | Detection of SLNs will occur within surgery, on average this surgery will take 1-2 hours for each participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between sentinel node status for disease and non-sentinel node disease status | The pathological evaluation of the sentinel lymph nodes (positive or negative) will be compared to the status of the non-sentinel nodes removed to determine whether the sentinel nodes accurately reflected the same status as the non-sentinel nodes. | Following surgery and pathological evaluation of all removed nodes, up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial cancer, Sentinel lymph node, Indocyanine green, Near infrared imaging