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

Phase 3

Completed

• Conditions: Endometrial Neoplasms
• Interventions: Procedure: Sentinel lymph node biopsy

• Registration Number: NCT02564276
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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 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.

Study Timeline

• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-09-30
• Study Start: 2016-02
• Status Verified: 2016-06
• Primary Completion: 2017-04
• Study Completion: 2017-07
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indocyanine Green on the right side	Sentinel lymph node biopsy	Indocyanine Green will be injected on the right side of the cervix and Methylene blue on the left side of the cervix.
Methylene Blue on the right side	Sentinel lymph node biopsy	Methylene blue will be injected on the right side of the cervix and Indocyanine Green on the left side of the cervix.

Primary Outcome Measures

Name	Time	Method
the difference in the proportion of hemipelves with successful detection of SLN according to the dye used	at time of surgery

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Montréal Hôpital Saint Luc; 🇨🇦 Montréal, Quebec, Canada