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

Endometrial Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564276
• Other study ID #: CE 15.114
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2015
• Last updated: January 23, 2018
• Start date: February 2016
• Est. completion date: July 2017

Study information

• Verified date: June 2016
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Procedure:
• Sentinel lymph node biopsy

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire Montréal Hôpital Saint Luc	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Abu-Rustum NR, Alektiar K, Iasonos A, Lev G, Sonoda Y, Aghajanian C, Chi DS, Barakat RR. The incidence of symptomatic lower-extremity lymphedema following treatment of uterine corpus malignancies: a 12-year experience at Memorial Sloan-Kettering Cancer Ce — View Citation

Ballester M, Dubernard G, Lécuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Daraï E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENT — View Citation

Barlin JN, Khoury-Collado F, Kim CH, Leitao MM Jr, Chi DS, Sonoda Y, Alektiar K, DeLair DF, Barakat RR, Abu-Rustum NR. The importance of applying a sentinel lymph node mapping algorithm in endometrial cancer staging: beyond removal of blue nodes. Gynecol — View Citation

Cormier B, Rozenholc AT, Gotlieb W, Plante M, Giede C; Communities of Practice (CoP) Group of Society of Gynecologic Oncology of Canada (GOC). Sentinel lymph node procedure in endometrial cancer: A systematic review and proposal for standardization of fut — View Citation

Creasman WT, Morrow CP, Bundy BN, Homesley HD, Graham JE, Heller PB. Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group Study. Cancer. 1987 Oct 15;60(8 Suppl):2035-41. — View Citation

Dankert J, Bouma J. Recurrent acute leg cellulitis after hysterectomy with pelvic lymphadenectomy. Br J Obstet Gynaecol. 1987 Aug;94(8):788-90. — View Citation

Desai PH, Hughes P, Tobias DH, Tchabo N, Heller PB, Dise C, Slomovitz BM. Accuracy of robotic sentinel lymph node detection (RSLND) for patients with endometrial cancer (EC). Gynecol Oncol. 2014 Nov;135(2):196-200. doi: 10.1016/j.ygyno.2014.08.032. Epub 2 — View Citation

Querleu D, Leblanc E, Cartron G, Narducci F, Ferron G, Martel P. Audit of preoperative and early complications of laparoscopic lymph node dissection in 1000 gynecologic cancer patients. Am J Obstet Gynecol. 2006 Nov;195(5):1287-92. Epub 2006 May 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the difference in the proportion of hemipelves with successful detection of SLN according to the dye used		at time of surgery