Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue

Launched by DOKUZ EYLUL UNIVERSITY · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help doctors find important lymph nodes during surgery for early-stage endometrial cancer, which is cancer of the lining of the uterus. Currently, doctors use a dye called methylene blue injected into two spots on the cervix (the lower part of the uterus) to map these lymph nodes. This study is testing whether injecting the dye into four spots instead of two can improve how well doctors can identify these lymph nodes, which helps guide treatment.

Women who have been diagnosed with stage I endometrial cancer and meet certain health criteria may be eligible to join. To participate, patients should not have advanced cancer, other serious health problems, or allergies to the dye used in the study. During the surgery, participants will receive the dye injections, and the surgical team will check how well the lymph nodes can be mapped using either the two-spot or four-spot injection method. This study is currently looking for volunteers, and it aims to improve surgical techniques that could help future patients receive more accurate treatment.

Gender

FEMALE

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 Dysfunction
• • • Individuals with hepatic dysfunction and a MELD score ≥ 10 and creatinine ≥ 2·0 mg/dl patients.