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

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

This test checks whether using four cervical methylene blue injections instead of the usual two helps surgeons find sentinel lymph nodes in people with newly diagnosed stage I endometrial cancer who are having surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Dokuz Eylul University (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Ankara and 1 other locations)
• Trial ID: NCT07040657 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people with pathologically confirmed, preoperative stage I endometrial cancer who are scheduled for surgical staging and have no allergy to methylene blue or iodine.

Not a fit: People with clinically or radiologically positive lymph nodes, metastatic disease, prior pelvic dissection or radiation, cervical tumors >2 cm, or methylene blue allergy are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, the four-point injection could increase sentinel lymph node detection rates and reduce the need for wider lymph node removal during surgery.

How similar studies have performed: Previous SLN mapping work has shown improved detection with some tracers and varied injection techniques, but evidence for a four-point cervical methylene blue injection is limited and not well established.

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.

Where this trial is running

Ankara and 1 other locations

• Ankara University — Ankara, Turkey (Türkiye) (RECRUITING)
• Dokuz Eylul University — Izmir, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Ibrahim Yalcin, MD

Conditions: Endometrial Neoplasms, Endometrial Cancer Stage I, Sentinel Lymph Node, Metastasis, endometrial neoplasm, methylene blue, metastasis, cervix