Two-point versus four-point cervical methylene blue injections for sentinel lymph node mapping in stage I endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial enrolls patients with preoperative stage I endometrial cancer and randomizes them to receive either the standard two-point or an experimental four-point cervical injection of methylene blue during surgery. Surgeons will then attempt sentinel lymph node (SLN) mapping and record SLN detection rates and mapping success. The primary outcome is the difference in SLN detection rates between the two injection techniques. Results will show whether increasing injection sites improves mapping using the low-cost methylene blue tracer in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ankara University
  Ankara, Turkey (Türkiye) Recruiting
• Dokuz Eylul University
  Izmir, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Ibrahim Yalcin, MD
• Email: ibrahimyalcin73@gmail.com
• Phone: +90 505 265 60 24

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.