Study Comparing Two-Point Versus Four-Point Methylene Blue Injection
for Sentinel Lymph Node Mapping in Early Stage Endometrial Cancer
Led by Dokuz Eylul University · Updated on 2025-06-27
100
Participants Needed
2
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
This trial studies lymph node mapping in patients newly diagnosed with stage I endometrial cancer undergoing surgery. It compares a standard 2-point cervical injection of methylene blue dye with a newer 4-point injection method to see if increasing injection sites improves sentinel lymph node SLN detection rates. The research aims to provide detailed insights into whether the 4-point injection offers an advantage for better mapping success.
Participants are randomly assigned to one of two groups one group receives injections at two cervix locations 3 and 9 oclock, and the other group receives injections at four different cervix sites 2, 4, 8, and 10 oclock. Both groups undergo the SLN mapping procedure using methylene blue dye to identify lymph nodes draining the uterus. This is a randomized controlled trial led by Dokuz Eylul University.
During the study, researchers evaluate SLN detection rates, sensitivity and specificity of SLN biopsy for detecting metastases, and the rate of positive SLNs. They also monitor procedure duration, injection-related side effects, anatomical distribution of SLNs, and surgical complications. Participants are followed closely for one month to assess any complications and side effects related to the injection and surgery.
CONDITIONS
Brief Title
Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue
Research Team
I
Ibrahim Yalcin, MD
A
Ali Hakan Kula, MD
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Diagnosed with stage I endometrial cancer based on CT and PET-CT imaging
Pathologically confirmed diagnosis of stage I endometrial cancer
Female
Aged 18 to 75 years
You will not qualify if you...
Diagnosed with dementia
Allergies to methylene blue or iodine
Received active treatment for another malignancy within the past 5 years
Unable to perform pelvic lymphadenectomy or history of prior pelvic lymphadenectomy
Multiple and confluent lymph nodes positive on FDG-PET/CT (not stage I)
Clinically or radiologically positive lymph nodes or metastatic disease
History of pelvic dissection and/or radiation therapy
Advanced cervical or uterine cancer
T3/T4 lesions
Cervical tumors larger than 2 cm
Hepatic dysfunction with MELD score ≥ 10 and creatinine ≥ 2.7 mg/dl
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - 1 day
Participants undergo sentinel lymph node mapping using methylene blue injection into the cervix to identify lymph nodes draining the uterus. This involves either a 2-point or 4-point injection technique during surgery.
1 surgical procedure visit
Follow-up
Duration - 1 month
Participants are monitored for injection-related side effects and surgical complications after the procedure.
Follow-up visits as needed during 1 month post-procedure
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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