Sentinel Lymph Node in Early-Stage Endometrium Cancer

NCT06163963 | Recruiting DMC

• 1 other identifier: 2023/2015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective study is to investigate whether the detection rate of sentinel lymph node (SLN) with double tracer injected at two different sites may be increased compared to the standard use of a single tracer with single site (cervix) injection in early-stage endometrial cancer.

Conditions

Sentinel Lymph Node; Endometrial Cancer

Keywords

double tracer, endometrial cancer, sentinel lymph node

Outcome Measures

Primary Outcomes (1)

• Detection rate of sentinel lymph nodes with double tracer in early stage endometrial carcinoma

  Detection rates of sentinel lymph nodes for both tracers in every pelvic and paraaortic lymph node basin are the primary outcome of the study.Sentinel lymph node detection rates of each region (pelvic, obturator, inframesenteric para-aortic, supra-mesenteric - infrarenal para-aortic), bilaterality/ unilaterality and staining with single or double tracer will be discussed compared to literature data.

  From the day of surgery to final pathology report (2 weeks)

Study Arms (1)

Sentinel Lymph Node Mapping With Double Tracer in Endometrium Cancer (Single Arm)

EXPERIMENTAL

Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer (Single Arm)

Diagnostic Test: Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer; Diagnostic Test: charcoal injection to uterus to map sentinel lymph nodes

Interventions

Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer DIAGNOSTIC_TEST

This is a single arm interventional prospective study. Sentinel lymph node detection rate of the tracer injected in cervix (ICG- indocyanine green) before operation and the second tracer injected in uterine fundal subserosa (sterile charcoal black) at the start of operation are investigated. It is anticipated that additional tracer used in the uterine serosa may overcome the insufficiency (or increase the detection rate) of the standard single tracer injected in cervix for detection rate of sentinel lymph nodes, especially in paraaortic sentinel lymph nodes.

Sentinel Lymph Node Mapping With Double Tracer in Endometrium Cancer (Single Arm)

charcoal injection to uterus to map sentinel lymph nodes DIAGNOSTIC_TEST

During surgery for endometrial cancer, charcoal injection to uterus to map sentinel lymph nodes in para aortic area besides the classic ınjection of indocyanine green for pelvic sentinel lymph node mapping.

Sentinel Lymph Node Mapping With Double Tracer in Endometrium Cancer (Single Arm)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Female - endometrial carcinoma
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have preoperative histologic diagnosis of endometrial carcinoma
• Must be in early stage ( stage1 and 2) endometrial carcinoma radiologically and clinically
• Must have written informed consent

You may not qualify if:

• Possible allergic reaction to commonly used drugs
• Medical or surgical contraindications for comphrensive staging
• Preoperative or intraoperative findings of advanced endometrial cancer

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Medical Faculty Dept. of Obstet Gynecol, Division of Gynecologic Oncology

Istanbul, Istanbul / Turkey, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Crosbie EJ, Kitson SJ, McAlpine JN, Mukhopadhyay A, Powell ME, Singh N. Endometrial cancer. Lancet. 2022 Apr 9;399(10333):1412-1428. doi: 10.1016/S0140-6736(22)00323-3.

  PMID: 35397864 BACKGROUND

• Cibula D, Oonk MH, Abu-Rustum NR. Sentinel lymph node biopsy in the management of gynecologic cancer. Curr Opin Obstet Gynecol. 2015 Feb;27(1):66-72. doi: 10.1097/GCO.0000000000000133.

  PMID: 25502426 BACKGROUND

• Lee YC, Lheureux S, Oza AM. Treatment strategies for endometrial cancer: current practice and perspective. Curr Opin Obstet Gynecol. 2017 Feb;29(1):47-58. doi: 10.1097/GCO.0000000000000338.

  PMID: 27941361 BACKGROUND

• van den Heerik ASVM, Horeweg N, de Boer SM, Bosse T, Creutzberg CL. Adjuvant therapy for endometrial cancer in the era of molecular classification: radiotherapy, chemoradiation and novel targets for therapy. Int J Gynecol Cancer. 2021 Apr;31(4):594-604. doi: 10.1136/ijgc-2020-001822. Epub 2020 Oct 20.

  PMID: 33082238 BACKGROUND

• Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.

  PMID: 28566221 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

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

Study Officials

• Samet TOPUZ, PROF. DR.

  ISTANBUL UNİVERSİTY MED FAC DEPT. OF OBSTET AND GYNECOL. DIVISION OF GYNECOLOGİC ONCOLOGY

  STUDY DIRECTOR

Central Study Contacts

Mustafa ALBAYRAK, MD

CONTACT

+905326871051; mustafaalbayrak@icloud.com

Yagmur MİNARECİ, MD

CONTACT

+905053574361; yagmurminareci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single arm interventional study aiming at the comparison of the effectiveness of detection for sentinel lymph node biopsy using double tracer compared to classic single tracer in early stage endometrial cancer. So, we aimed to investigate whether the sentinel lymph node detection rates may be improved with double tracer injected at two different sites (charcoal carbon black dye injected in subserosa and ICG injected into cervix) compared to standard single tracer injected in early-stage endometrial cancer, especially the para-aortic sentinel lymph nodes. Sterile charcoal carbon black dye is an agent previously used for sentinel lymph node detection in various cancers such as breast cancer. Sentinel lymph node detection rates of each region (pelvic, obturator, inframesenteric para-aortic, supra-mesenteric - infrarenal para-aortic), bilaterality/ unilaterality and staining with single or double tracer will be discussed compared to literature data.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: July 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: November 25, 2024

Record last verified: 2023-12

Locations

TU (1)