Sentinel Lymph Node Mapping With Different Injection Sites of ICG in Endometrium Cancer

NCT06656949 | Recruiting

• 1 other identifier: KYLL-202404-005-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Optimizing Sentinel lymph node detection procedure in endometrium cancer

  intraoperative day 0

• The difference Sentinel lymph node detection rate with Double Injection Sites and one injection site

  intraoperative day 0

• Postoperative complications

  postoperative up to day 30

Study Arms (2)

sentinel lymph node mapping with One injection site (cervix) group

ACTIVE COMPARATOR

injecting indocyanine green (ICG) dye Intraoperative in cervix

Procedure: injecting indocyanine green (ICG) dye Intraoperative

sentinel lymph node mapping with two injection site (cervix-uterus) group

EXPERIMENTAL

injecting indocyanine green (ICG) dye Intraoperative in cervix and uterus

Procedure: injecting indocyanine green (ICG) dye Intraoperative

Interventions

injecting indocyanine green (ICG) dye Intraoperative PROCEDURE

injecting indocyanine green (ICG) dye Intraoperative for patients with endometrial cancer

sentinel lymph node mapping with One injection site (cervix) group; sentinel lymph node mapping with two injection site (cervix-uterus) group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 1.Age \>18 and \<80 years old
• \. The pathological diagnosis was epithelial ovarian cancer
• Survival time is expected to exceed 3 months
• Signed consent form

You may not qualify if:

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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital，Shandong University

Jinan, Shandong, 250012, China

RECRUITING

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

Central Study Contacts

Jin Peng, PhD

CONTACT

86-18560088205; jin_peng@outlook.com

Youzhong Zhang, PhD

CONTACT

86-18560081866; zhangyouzhong@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of OB&G department

Model Details: The study design is a two-arm, randomized, controlled trial.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 24, 2024
• Study Start: October 30, 2024
• Primary Completion: October 30, 2025
• Study Completion: January 30, 2026
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)