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

NCT ID: NCT02564276

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-07-31

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.

Conditions

Endometrial Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sentinel lymph node biopsy

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

Sentinel lymph node biopsy

Intervention Type: PROCEDURE

Interventions

Sentinel lymph node biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Béatrice Cormier, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier Universitaire Montréal Hôpital Saint Luc

Montreal, Quebec, Canada

Countries

Canada

References

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Reference Type: RESULT

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Other Identifiers

CE 15.114

Identifier Type: -

Identifier Source: org_study_id