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

October 23, 2024 updated by: Youzhong Zhang, Qilu Hospital of Shandong University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital，Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: intraoperative day0
IGC positive Sentinel lymph node detection in paraaoritc lymph node will be assessed
intraoperative day0
Sentinel lymph node technique accuracy
Time Frame: postoperative up to day7
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
Time Frame: intraoperative day 0
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
Time Frame: intraoperative day 0
assessing difference IGC positive sentinel lymph node detection rate with Double Injection Sites and one injection site
intraoperative day 0
Postoperative complications
Time Frame: postoperative up to day 30
Postoperative complications including damage of insestine , urethra and bladder
postoperative up to day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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