Improving detection of lymph nodes in early-stage endometrial cancer
Sentinel Lymph Node Mapping with Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer
This study is testing a new way to find lymph nodes in early-stage endometrial cancer to see if using two tracers instead of one can help patients avoid more invasive procedures and improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul, Istanbul / Turkey) |
| Trial ID | NCT06163963 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to enhance the detection rate of sentinel lymph nodes (SLN) in early-stage endometrial cancer by using a double tracer injected at two different sites, compared to the standard single tracer method. Endometrial cancer is the most prevalent gynecologic cancer, and accurate staging is crucial for treatment and prognosis. The study seeks to determine if this new approach can reduce the need for more invasive lymphadenectomy procedures, which carry significant risks. By focusing on sentinel lymph node biopsy, the study hopes to improve patient outcomes while minimizing complications associated with traditional staging methods.
Who should consider this trial
Good fit: Ideal candidates are women with a preoperative histologic diagnosis of early-stage endometrial carcinoma (stage 1 and 2).
Not a fit: Patients with advanced endometrial cancer or those with contraindications for comprehensive staging may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate staging of early-stage endometrial cancer while reducing surgical risks for patients.
How similar studies have performed: Previous studies have shown variable success rates for sentinel lymph node detection in endometrial cancer, indicating that while this approach is established, the specific methodology being tested may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Must have preoperative histologic diagnosis of endometrial carcinoma 2. Must be in early stage ( stage1 and 2) endometrial carcinoma radiologically and clinically 3. Must have written informed consent Exclusion Criteria: 1. Possible allergic reaction to commonly used drugs 2. Medical or surgical contraindications for comphrensive staging 3. Preoperative or intraoperative findings of advanced endometrial cancer
Where this trial is running
Istanbul, Istanbul / Turkey
- Istanbul University Medical Faculty Dept. of Obstet Gynecol, Division of Gynecologic Oncology — Istanbul, Istanbul / Turkey, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Mustafa ALBAYRAK, MD
- Email: mustafaalbayrak@icloud.com
- Phone: +905326871051
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.