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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Current Primary Outcome: the difference in the proportion of hemipelves with successful detection of SLN according to the dye used [ Time Frame: at time of surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Centre hospitalier de l'Université de Montréal (CHUM)

Dates:
Date Received: September 29, 2015
Date Started: February 2016
Date Completion: February 2017
Last Updated: June 27, 2016
Last Verified: June 2016