Sentinel Lymph Node Mapping With Different Injection Sites of ICG in Endometrium Cancer (SLN-EC-01)

A Prospective, Randomized Trial Comparing the Different Injection Sites of Indocyanine Green (ICG) in Sentinel Lymph Node Mapping in Patients With Endometrial Cancer

The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy (SLNB) procedure by comparing different method performed in patients with endometrial cancer. The aim of this study is to investigate whether the detection rate of sentinel lymph node (SLN) with two different injection sites may be increased compared to the standard use with single site (cervix) injection in endometrial cancer.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Procedure: injecting indocyanine green (ICG) dye Intraoperative

Detailed Description

The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed if sentinel lymph node is positive.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin Peng, PhD; Phone Number: 86-18560088205; Email: jin_peng@outlook.com
• Study Contact Backup: Name: Youzhong Zhang, PhD; Phone Number: 86-18560081866; Email: zhangyouzhong@vip.sina.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital，Shandong University
      • Contact: Jin Peng, PhD; Phone Number: 86-18560088205; Email: jin_peng@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • 1.Age >18 and <80 years old

  • 2. The pathological diagnosis was epithelial ovarian cancer
  • 3.Survival time is expected to exceed 3 months
  • 4.Signed consent form

Exclusion Criteria:

• 1. Patients with myocardial infarction or stroke, or unstable angina pectoris or decompensated heart function
• 2.Patients with a history of exhaustion or deep vein thrombosis;
• 3. Liver insufficiency (transaminase >2.5 times the upper limit of the standard);
• 4. Renal insufficiency (serum muscle liver >2 times the standard upper limit);
• 5. Pregnancy and perinatal patients;
• 6. History of major organ transplantation and immune disease;
• 7. Psychiatric condition or language barriers
• 8. Alcohol or drug abuser (current or previous)
• 9. Unable or unwilling to sign informed consent or comply with study requirements;
• 10. Patients with other malignant tumors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sentinel lymph node mapping with One injection site (cervix) group; injecting indocyanine green (ICG) dye Intraoperative in cervix	Procedure: injecting indocyanine green (ICG) dye Intraoperative; injecting indocyanine green (ICG) dye Intraoperative for patients with endometrial cancer
Experimental: sentinel lymph node mapping with two injection site (cervix-uterus) group; injecting indocyanine green (ICG) dye Intraoperative in cervix and uterus	Procedure: injecting indocyanine green (ICG) dye Intraoperative; injecting indocyanine green (ICG) dye Intraoperative for patients with endometrial cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
paraaortic Sentinel lymph node detection rates	IGC positive Sentinel lymph node detection in paraaoritc lymph node will be assessed	intraoperative day0
Sentinel lymph node technique accuracy	Sensitivity and specificity measure of the sentinel lymph node for detecting the lymphatic metastasis	postoperative up to day7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimizing Sentinel lymph node detection procedure in endometrium cancer	Optimizing injectiong site, tow site injection vs one site injection	intraoperative day 0
The difference Sentinel lymph node detection rate with Double Injection Sites and one injection site	assessing difference IGC positive sentinel lymph node detection rate with Double Injection Sites and one injection site	intraoperative day 0
Postoperative complications	Postoperative complications including damage of insestine , urethra and bladder	postoperative up to day 30

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: KYLL-202404-005-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No