Clinical trial · Interventional
Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG
Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue (ISB) and Indocyanine Green Dyes (ICG) With Fluorescence Imaging
- 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 investigators hypothesis is that if sensitivity and specificity are found to be significantly higher than the current reports with Technesium-99 and ISB colorimetric dye, SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby limiting peri-operative morbidity. SLN biopsies might also improve the detection of metastatic disease, essentially lowering the recognized false-negative rate of standard lymphadenectomy analyzed by routine H\&E pathologic analysis.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG dye and FireFly fluorescence imaging | Device | — | UNRESOLVED |
| ISB dye and standard white light imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ISB dye, standard white light
- description
- SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.
- interventionNames
- Device: ISB dye and standard white light imaging
- type
- EXPERIMENTAL
- label
- ICG dye, FireFly fluorescence imaging
- description
- SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.
- interventionNames
- Device: ISB dye and standard white light imaging
- Device: ICG dye and FireFly fluorescence imaging
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient must be ≥18 and ≤85 years of age. 2. The patient must be female. 3. The patient must be willing and able to provide informed consent. 4. The patient is willing and able to comply with the study protocol. 5. The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy. 6. The patient agrees to follow-up examinations out to 6-weeks post-treatment Exclusion Criteria: 1. The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy. 2. The patient has known or suspected allergies to iodine, ICG or ISB. 3. The patient has hepatic dysfunction confirmed by elevated liver function studies (i.e., hepatic enzyme SGOT, SGPT or Bilirubin \> 2 x normal (based on reference values from the laboratory used by the patient)
References
Publications (0)
Data not yet available