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

January 23, 2018 updated by: Centre hospitalier de l'Université de Montréal (CHUM)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada
        • Centre Hospitalier Universitaire Montréal Hôpital Saint Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indocyanine Green on the right side
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
Experimental: Methylene Blue on the right side
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Béatrice Cormier, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 15.114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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