Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

Study Overview
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Brief Summary
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The main purpose of the study is to evaluate the detection rate and accuracy of fluorescence imaging in endometrial cancer staging by sentinel node assessment.

Detailed Description
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In many cancer types, such as breast cancer and melanoma, sentinel node assessment has become the standard of care surgical treatment. Sentinel nodes are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. Removal of a sentinel node for examination accurately predicts whether the cancer has spread to other nodes further along in the nodal chain. Fluorescence imaging with ICG dye (Indocyanine Green) has been used to detect lymph nodes in patients with gastric, colorectal and breast cancer. To date, the use of this technique in endometrial cancer has not been reported.

Official Title
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A Prospective Investigation of the Use of Fluorescence Imaging on the da Vinci Surgical System for Ultrastaging of Endometrial Cancer by Sentinel Node Assessment

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Procedure: Fluorescence-guided sentinel lymph node detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy proven endometrial carcinoma Must have planned to undergo standard endometrial cancer staging surgery as part of their routine clinical care Must be 18 years of age and older Must be able to comply with all the study procedures Exclusion Criteria: Significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, with total bilirubin > 1.5 times normal, and/or SGOT > 2 times normal Uremia, serum creatinine > 2.0 mg/dl Previous history of adverse reaction or allergy to ICG dye, iodine, shellfish, or iodine dyes Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage Pregnant Currently participating in a drug, biologic and/or device treatment study Any medical condition that would normally prevent someone from receiving general anesthesia or undergoing standard surgical procedures

Ages Eligible for Study
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Minimum Age: 18 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>Fluorescence-guided sentinel lymph node detection | Procedure: Fluorescence-guided sentinel lymph node detection<br>* During standard endometrial cancer surgery, ICG dye will be injected into the cervix to identify sentinel lymph nodes in the pelvis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer. |  | Average expected time of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation. | In cancer, upstaging is changing the stage used to describe a patient's cancer from a lower stage (less extensive) to a higher stage (more extensive). The sentinel lymph nodes removed during the flourescence guided surgery will be examined microscopically to determine how often upstaging occurred. | Average expected time of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer of Endometrium, Cancer of the Endometrium, Carcinoma of Endometrium, Endometrial Carcinoma, Endometrium Cancer, Neoplasms, Endometrial