Clinical trial · Interventional
Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease
Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study
NCT03838055CI-TRIAL-00037050unknownN/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)
Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.
Conditions
Conditions (3)
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 |
| Lymphedema | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of tracer ( ICG) and detection of sentinel lymph nodes | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SLN only
- description
- Pelvic SLN's defined by ICG injected cervically
- interventionNames
- Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes
Primary outcomes (2)
- measure
- Detection rate of pelvic metastatic disease in endometrial cancer
- timeFrame
- 3 years from start inclusion with an interim analysis after 150 patients
- description
- The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases
- measure
- Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes
- timeFrame
- 3 years from start inclusion
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Women of age 18 years and older at the time of informed consent. * Women with a pathologically proven endometrial carcinoma of any histologic subtype or grade, clinically stage I-II planned for primary surgery * A uterine size allowing minimally invasive surgery * Women must be able to understand and sign an informed consent in Swedish language. * Absence of any exclusion criteria Exclusion Criteria: * Non consenting patients * Ongoing pregnancy * Inability to understand written and/or oral study information * WHO performance status or conditions contraindicating adjuvant oncological treatment (WHO III or more) * Previous lower limb lymphedema ( only for the lymphedema part of study) * Evidence of locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography. * Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion. * Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion * Allergy to Iodine * Patients with a known liver disease * Patients with a bleeding disorder or mandatory antithrombotic treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.