Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue
Recruiting now · Not applicable
Conditions studied: Endometrial Neoplasms, Endometrial Cancer Stage I, Sentinel Lymph Node, Metastasis
In brief
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.
Key facts
- Study ID
- NCT07040657
- Run by
- Dokuz Eylul University
- People needed
- 100
- Starts
- 2025-05-01
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2025-06-27
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 Dysfunction
- Individuals with hepatic dysfunction and a MELD score ≥ 10 and creatinine ≥ 2·0 mg/dl patients.
Where it is running
- Ankara University — Ankara, Turkey (Türkiye) (enrolling)
- Dokuz Eylul University — Izmir, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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