NCT07040657 Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue
| NCT ID | NCT07040657 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dokuz Eylul University |
| Condition | Endometrial Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-05-01 |
Trial Parameters
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Brief Summary
This clinical trial evaluates lymph node mapping in newly diagnosed endometrial cancer patients undergoing surgery. The standard technique uses a 2-point methylene blue cervical injection. The study aims to determine if increasing injection points improves mapping success.
Eligibility Criteria
Inclusion Criteria: * Individuals diagnosed with stage I endometrial cancer based on CT and PET-CT imaging. * Individuals with a pathologically confirmed diagnosis of stage I endometrial cancer. Exclusion Criteria: Medical Conditions * Individuals diagnosed with dementia. * Individuals with allergies to methylene blue or iodine. * Individuals who have received active treatment for another malignancy within the past five years. * Inability to successfully perform PLD (pelvic lymphadenectomy) or history of prior PLD. * Women with multiple and confluent lymph nodes identified as positive on FDG-PET/CT (such cases are not considered stage I). Cancer-Related Conditions * Individuals with clinically or radiologically identified positive lymph nodes or metastatic disease. * Individuals with a history of pelvic dissection and/or radiation therapy. * Individuals with advanced cervical or uterine cancer. * Individuals with T3/T4 lesions. * Individuals with cervical tumors larger than 2 cm. Organ