Clinical trial · Interventional
Lymph Node Mapping in Patients With Endometrial Cancer
Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue and Indocyanine Green Dyes With Fluorescence Imaging
NCT01818739CI-TRIAL-00064882completedN/AResults postedClinicalTrials.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 studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.
Conditions
Conditions (1)
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 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indocyanine green solution | Drug | — | UNRESOLVED |
| isosulfan blue | Drug | — | UNRESOLVED |
| sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
| sentinel lymph node detection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sentinel lymph node detection
- description
- Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
- interventionNames
- Procedure: sentinel lymph node detection
- Drug: indocyanine green solution
- Drug: isosulfan blue
- Procedure: sentinel lymph node biopsy
Primary outcomes (1)
- measure
- Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease
- timeFrame
- average of 1-14 days after the procedure when final pathologic evaluation has been completed
- description
- NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * The patient must be willing and able to provide informed consent * The patient is willing and able to comply with the study protocol * The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy * The patient agrees to follow-up examinations out to 5-years post-treatment Exclusion Criteria: * The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy * The patient has known or suspected allergies to iodine, indocyanine green (ICG) or isosulfan blue (ISB) * The patient has hepatic dysfunction confirmed by bilirubin \> 2 x normal (based on reference values from the laboratory used by the patient)
References
Publications (1)
- BACKGROUNDBackes FJ, Cohen D, Salani R, Cohn DE, O'Malley DM, Fanning E, Suarez AA, Fowler JM. Prospective clinical trial of robotic sentinel lymph node assessment with isosulfane blue (ISB) and indocyanine green (ICG) in endometrial cancer and the impact of ultrastaging (NCT01818739). Gynecol Oncol. 2019 Jun;153(3):496-499. doi: 10.1016/j.ygyno.2019.03.252. Epub 2019 Apr 4. PMID 31230614