Indocyanine Green Versus Blue Dye for Detection of Sentinel Lymph Node In Endometrial Cancer

Study Overview
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Brief Summary
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To determine the difference in the proportion of hemipelves with successful detection of Sentinel Lymph Node according to the dye used (indocyanine green with near-infrared imaging vs blue dye) in women with endometrial cancer.

Detailed Description
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In the past few years, Sentinel Lymph Node (SLN) procedure has emerged as an interesting solution to the debate on lymphadenectomy in endometrial cancer. Using blue-dye is inexpensive but results in an unsatisfactory detection rate of SLN. IndoCyanine Green (ICG) with near-infrared imaging is a novel technology for SLN mapping and initial reports on the use of ICG have shown high detection rate. In the present study, we aim to determine precisely the increase in detection rate of SLN associated with the use of ICG instead of blue dye. This randomized controlled trial will include patients with preoperative stage I endometrial carcinoma. All included women will undergo SLN mapping with blue dye in one hemipelvis and ICG in the other hemipelvis. Randomization will concern the side of the hemipelvis in which blue dye vs ICG mapping is used, so that the patient's contralateral hemipelvis will serve as a control to her ipsilateral hemipelvis. The primary endpoint is the difference in the proportion of hemipelves with successful detection of SLN according to the dye used. The unique precise information gained from the present study will contribute to determine whether the benefit of the use of ICG over blue dye is sufficient to justify the expense of its use.

Official Title
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Indocyanine Green Versus Blue Dye for Detection of Sentinel Lymph Node In Endometrial Cancer

Conditions
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Endometrial Neoplasms

Intervention / Treatment
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* Procedure: Sentinel lymph node biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients with endometrial carcinoma proven by endometrial biopsy or curettage AND preoperative FIGO (International Federation of Gynecology and Obstetrics) stage I AND intended for staging via laparoscopic or robotic surgery AND Patients must be older than 18 year-old, able to read French or English. Exclusion Criteria: preoperative FIGO stages II to IV previous pelvic or paraaortic lymphadenectomy or radiotherapy surgery that could change the uterine lymphatic drainage (myomectomy) iodine allergy pregnancy.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indocyanine Green on the right side<br>Indocyanine Green will be injected on the right side of the cervix and Methylene blue on the left side of the cervix. | Procedure: Sentinel lymph node biopsy<br> <br> |
| Experimental: Methylene Blue on the right side<br>Methylene blue will be injected on the right side of the cervix and Indocyanine Green on the left side of the cervix. | Procedure: Sentinel lymph node biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference in the proportion of hemipelves with successful detection of SLN according to the dye used |  | at time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indocyanine Green, Sentinel Lymph Node Biopsy