Clinical trial · Interventional
Sentinel Lymph Node in Early-Stage Endometrium Cancer
Sentinel Lymph Node Mapping with Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer
NCT06163963CI-TRIAL-00082938unknownN/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)
The aim of this prospective study is to investigate whether the detection rate of sentinel lymph node (SLN) with double tracer injected at two different sites may be increased compared to the standard use of a single tracer with single site (cervix) injection in early-stage endometrial cancer.
Conditions
Conditions (2)
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 | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| charcoal injection to uterus to map sentinel lymph nodes | Diagnostic Test | — | UNRESOLVED |
| Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentinel Lymph Node Mapping With Double Tracer in Endometrium Cancer (Single Arm)
- description
- Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer (Single Arm)
- interventionNames
- Diagnostic Test: Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer
- Diagnostic Test: charcoal injection to uterus to map sentinel lymph nodes
Primary outcomes (1)
- measure
- Detection rate of sentinel lymph nodes with double tracer in early stage endometrial carcinoma
- timeFrame
- From the day of surgery to final pathology report (2 weeks)
- description
- Detection rates of sentinel lymph nodes for both tracers in every pelvic and paraaortic lymph node basin are the primary outcome of the study.Sentinel lymph node detection rates of each region (pelvic, obturator, inframesenteric para-aortic, supra-mesenteric - infrarenal para-aortic), bilaterality/ unilaterality and staining with single or double tracer will be discussed compared to literature data.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Must have preoperative histologic diagnosis of endometrial carcinoma 2. Must be in early stage ( stage1 and 2) endometrial carcinoma radiologically and clinically 3. Must have written informed consent Exclusion Criteria: 1. Possible allergic reaction to commonly used drugs 2. Medical or surgical contraindications for comphrensive staging 3. Preoperative or intraoperative findings of advanced endometrial cancer
References
Publications (5)
- BACKGROUNDCrosbie EJ, Kitson SJ, McAlpine JN, Mukhopadhyay A, Powell ME, Singh N. Endometrial cancer. Lancet. 2022 Apr 9;399(10333):1412-1428. doi: 10.1016/S0140-6736(22)00323-3. PMID 35397864
- BACKGROUNDCibula D, Oonk MH, Abu-Rustum NR. Sentinel lymph node biopsy in the management of gynecologic cancer. Curr Opin Obstet Gynecol. 2015 Feb;27(1):66-72. doi: 10.1097/GCO.0000000000000133. PMID 25502426
- BACKGROUNDLee YC, Lheureux S, Oza AM. Treatment strategies for endometrial cancer: current practice and perspective. Curr Opin Obstet Gynecol. 2017 Feb;29(1):47-58. doi: 10.1097/GCO.0000000000000338. PMID 27941361
- BACKGROUNDvan den Heerik ASVM, Horeweg N, de Boer SM, Bosse T, Creutzberg CL. Adjuvant therapy for endometrial cancer in the era of molecular classification: radiotherapy, chemoradiation and novel targets for therapy. Int J Gynecol Cancer. 2021 Apr;31(4):594-604. doi: 10.1136/ijgc-2020-001822. Epub 2020 Oct 20. PMID 33082238
- 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