Clinical trial · Interventional
Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery
A Prospective Investigation of the Use of Fluorescence Imaging on the da Vinci Surgical System for Ultrastaging of Endometrial Cancer by Sentinel Node Assessment
NCT01562106CI-TRIAL-00024839completedN/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 main purpose of the study is to evaluate the detection rate and accuracy of fluorescence imaging in endometrial cancer staging by sentinel node assessment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescence-guided sentinel lymph node detection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICG Dye
- description
- Fluorescence-guided sentinel lymph node detection
- interventionNames
- Procedure: Fluorescence-guided sentinel lymph node detection
Primary outcomes (1)
- measure
- Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.
- timeFrame
- Average expected time of 12 weeks
Secondary outcomes (1)
- measure
- Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.
- timeFrame
- Average expected time of 12 weeks
- description
- In cancer, "upstaging" is changing the stage used to describe a patient's cancer from a lower stage (less extensive) to a higher stage (more extensive). The sentinel lymph nodes removed during the flourescence guided surgery will be examined microscopically to determine how often upstaging occurred.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven endometrial carcinoma * Must have planned to undergo standard endometrial cancer staging surgery as part of their routine clinical care * Must be 18 years of age and older * Must be able to comply with all the study procedures Exclusion Criteria: * Significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, with total bilirubin \> 1.5 times normal, and/or SGOT \> 2 times normal * Uremia, serum creatinine \> 2.0 mg/dl * Previous history of adverse reaction or allergy to ICG dye, iodine, shellfish, or iodine dyes * Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage * Pregnant * Currently participating in a drug, biologic and/or device treatment study * Any medical condition that would normally prevent someone from receiving general anesthesia or undergoing standard surgical procedures
References
Publications (0)
Data not yet available
No reference posted for this study.