Mapping lymph nodes in endometrial cancer using different injection sites
A Prospective, Randomized Trial Comparing the Different Injection Sites of Indocyanine Green (ICG) in Sentinel Lymph Node Mapping in Patients With Endometrial Cancer
This study is testing whether using different injection sites for a dye can help find lymph nodes more accurately in women with endometrial cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06656949 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of sentinel lymph node biopsy (SLNB) in patients with endometrial cancer by comparing the detection rates of sentinel lymph nodes using two different injection sites of indocyanine green (ICG) dye versus the standard single site injection at the cervix. The procedure involves injecting ICG prior to surgery and utilizing fluorescent imaging systems to identify and remove sentinel lymph nodes, which will then be examined for cancer presence. If the sentinel lymph node is positive, a systematic pelvic lymphadenectomy will follow. This approach seeks to improve the accuracy of lymph node detection and potentially reduce unnecessary surgeries.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 80 diagnosed with endometrial cancer who are expected to survive more than three months.
Not a fit: Patients with significant cardiovascular issues, liver or renal insufficiency, or other major health concerns may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of lymph node detection in endometrial cancer, leading to better treatment outcomes.
How similar studies have performed: Other studies have shown promising results with sentinel lymph node mapping in various cancers, suggesting potential success for this approach in endometrial cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jinan, Shandong
- Qilu Hospital，Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Jin Peng, PhD
- Email: jin_peng@outlook.com
- Phone: 86-18560088205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.