Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
NCT07040657

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

Led by Dokuz Eylul University · Updated on 2025-06-27

100

Participants Needed

2

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with stage I endometrial cancer confirmed by CT and PET-CT imaging
  • Pathologically confirmed diagnosis of stage I endometrial cancer
Not Eligible

You will not qualify if you...

  • Diagnosed with dementia
  • Allergic to methylene blue or iodine
  • Received active treatment for another malignancy within the past five 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 210 and creatinine 2�b70 mg/dl

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Ankara University

Ankara, Turkey (Türkiye), 06230

Actively Recruiting

2

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Actively Recruiting

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Research Team

I

Ibrahim Yalcin, MD

CONTACT

A

Ali Hakan Kula, MD

CONTACT

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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