N/A
N=204
Lymph Node Mapping in Patients With Endometrial Cancer
Endometrial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01818739 ↗Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease — 98.8 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- sentinel lymph node detection (Procedure); indocyanine green solution (Drug); isosulfan blue (Drug); sentinel lymph node biopsy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease |
98.8 | — |
| SECONDARY Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining |
17 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01818739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.