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

NCT02564276 | Completed Phase 3

• 1 other identifier: CE 15.114
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Neoplasms

Keywords

Indocyanine Green; Sentinel Lymph Node Biopsy

Outcome Measures

Primary Outcomes (1)

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

  at time of surgery

Study Arms (2)

Indocyanine Green on the right side

EXPERIMENTAL

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

Methylene Blue on the right side

EXPERIMENTAL

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

Interventions

Sentinel lymph node biopsy PROCEDURE

Indocyanine Green on the right side; Methylene Blue on the right side

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier Universitaire Montréal Hôpital Saint Luc

Montreal, Quebec, Canada

Location

Related Publications (8)

• 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. doi: 10.1002/1097-0142(19901015)60:8+3.0.co;2-8.

  PMID: 3652025 RESULT

• 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 Center. Gynecol Oncol. 2006 Nov;103(2):714-8. doi: 10.1016/j.ygyno.2006.03.055. Epub 2006 Jun 5.

  PMID: 16740298 RESULT

• Dankert J, Bouma J. Recurrent acute leg cellulitis after hysterectomy with pelvic lymphadenectomy. Br J Obstet Gynaecol. 1987 Aug;94(8):788-90. doi: 10.1111/j.1471-0528.1987.tb03728.x.

  PMID: 3663535 RESULT

• 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. doi: 10.1016/j.ajog.2006.03.043. Epub 2006 May 3.

  PMID: 16677594 RESULT

• 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 Oncol. 2012 Jun;125(3):531-5. doi: 10.1016/j.ygyno.2012.02.021. Epub 2012 Feb 22.

  PMID: 22366409 RESULT

• 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 2014 Aug 28.

  PMID: 25175452 RESULT

• 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 future research. Gynecol Oncol. 2015 Aug;138(2):478-85. doi: 10.1016/j.ygyno.2015.05.039. Epub 2015 Jun 3.

  PMID: 26047592 RESULT

• Ballester M, Dubernard G, Lecuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Darai E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO). Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12.

  PMID: 21489874 RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Béatrice Cormier, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: September 30, 2015
• Study Start: February 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 25, 2018

Record last verified: 2016-06

Locations

CA (1)