Clinical trial · Interventional
Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue
Comparison of Two-Point and Four-Point Cervical Injection Techniques Using Methylene Blue for Sentinel Lymph Node Mapping in Endometrial Cancer
NCT07040657CI-TRIAL-00091520recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer Stage I | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastasis | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel Lymph Node Detection/Cervical Methylene Blue Injection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 2- Point Methylene Blue Injection
- description
- In the 2-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix: At the 3 o'clock position At the 9 o'clock position
- interventionNames
- Procedure: Sentinel Lymph Node Detection/Cervical Methylene Blue Injection
- type
- ACTIVE_COMPARATOR
- label
- 4- Point Methylene Blue Injection
- description
- In the 4-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix: At the 2 o'clock position At the 4 o'clock position At the 8 o'clock position At the 10 o'clock position
- interventionNames
- Procedure: Sentinel Lymph Node Detection/Cervical Methylene Blue Injection
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (14)
- BACKGROUNDSehnal B, Waldauf P, Matej R, Hruda M, Robova H, Drozenova J, Pichlik T, Zapletal J, Rob L, Halaska MJ. Comparison of tracer application methods for sentinel lymph node detection in open surgery patients with endometrial cancer: a retrospective cohort study. BMC Cancer. 2025 Apr 8;25(1):638. doi: 10.1186/s12885-025-14037-8. PMID 40200256
- BACKGROUNDHolloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28. PMID 28566221
- BACKGROUNDSalman L, Cusimano MC, Marchocki Z, Ferguson SE. Sentinel lymph node mapping in endometrial cancer: Current evidence and practice. J Surg Oncol. 2024 Jan;129(1):117-119. doi: 10.1002/jso.27550. Epub 2023 Dec 7. PMID 38059317
- BACKGROUNDLeitao MM Jr, Zhou QC, Gomez-Hidalgo NR, Iasonos A, Baser R, Mezzancello M, Chang K, Ward J, Chi DS, Long Roche K, Sonoda Y, Brown CL, Mueller JJ, Gardner GJ, Jewell EL, Broach V, Zivanovic O, Dowdy SC, Mariani A, Abu-Rustum NR. Patient-reported outcomes after surgery for endometrial carcinoma: Prevalence of lower-extremity lymphedema after sentinel lymph node mapping versus lymphadenectomy. Gynecol Oncol. 2020 Jan;156(1):147-153. doi: 10.1016/j.ygyno.2019.11.003. Epub 2019 Nov 25. PMID 31780238
- BACKGROUNDTerada S, Tanaka T, Murakami H, Tsuchihashi H, Toji A, Daimon A, Miyamoto S, Nishie R, Ueda S, Hashida S, Morita N, Maruoka H, Konishi H, Kogata Y, Taniguchi K, Komura K, Ohmichi M. Lymphatic Complications Following Sentinel Node Biopsy or Pelvic Lymphadenectomy for Endometrial Cancer. J Clin Med. 2023 Jul 7;12(13):4540. doi: 10.3390/jcm12134540. PMID 37445574
- BACKGROUNDAltin D, Taskin S, Ortac F, Tokgozoglu N, Vatansever D, Guler AH, Gungor M, Tasci T, Bese T, Turan H, Kahramanoglu I, Yalcin I, Celik C, Demirkiran F, Kose F, Arvas M, Ayhan A, Taskiran C. Diagnostic accuracy of sentinel node biopsy in non-endometrioid, high-grade and/or deep myoinvasive endometrial cancer: A Turkish gynecologic oncology group study (TRSGO-SLN-006). Gynecol Oncol. 2022 Mar;164(3):492-497. doi: 10.1016/j.ygyno.2022.01.009. Epub 2022 Jan 13.