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Completed

NCT Number: NCT02564276

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Universitaire Montréal Hôpital Saint Luc

Montreal, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sentinel Lymph Node Biopsy

Procedure

Primary outcomes

  1. the difference in the proportion of hemipelves with successful detection of SLN according to the dye used

    Time frame: at time of surgery

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2015
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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