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

Endometrial Neoplasms Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Endometrial Neoplasms

• NCT number: NCT02564276
• Study type: Interventional
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Status: Completed
• Phase: Phase 3
• Start date: February 2016
• Completion date: July 2017