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
I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in
endometrial cancer to predict nodal metastasis.
II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic
disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC
results and standard hematoxylin and eosin (H&E) results.
Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine
green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel
lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full
pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard
hysterectomy and salpingo-oophorectomy.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years for a total of 5 years according to the standard surveillance
guidelines for endometrial cancer.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
negative predictive value of sentinel lymph node prediction of metastatic disease
The detection rate is calculated as the number of patients with bilaterally detected pelvis SLN divided by a total number of patients who undergo labeling and SLN mapping. Sensitivity estimated as the proportion of true positives among the patients with pelvic lymph node metastases. 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, and subgroup analysis is done with a two-sided chi-square test or Fischer's exact test.
average of 1-14 days after the procedure when final pathologic evaluation has been completed
Floor Backes, MD
Ohio State University Comprehensive Cancer Center
United States: Institutional Review Board
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|