NCT02068820

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study objective is to compare two sentinel lymph node detection technologies \[fluorescence imaging and Indocyanine Green (ICG) dye verses standard laparoscopic colorimetric analysis using Isosulfan Blue (ISB) dye\] for sensitivity and specificity of detecting metastatic disease in pelvic lymph nodes of women with endometrial cancer undergoing robotic-assisted laparoscopic hysterectomy and lymphadenectomy. The following three specific aims would be addressed in this research proposal: Specific Aim 1: To determine the ability of mapping bilaterally pelvic SLN in women with endometrial cancer undergoing robotic-assisted laparoscopic staging comparing two different methods (i.e., comparing the combination of colorimetric analysis-ISB dye + fluorescence imaging-ICG dye vs. colorimetric analysis-ISB dye alone). Specific Aim 2: To estimate the negative predictive value (NPV) of pelvic SLN in endometrial cancer with respect to predicting nodal metastasis. Specific Aim 3: To evaluate 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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DEVICE	ISB dye and standard white light imaging	Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
DEVICE	ICG dye and FireFly fluorescence imaging	Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-02-21
• Last updated: 2019-09-10
• Results posted: 2019-09-10

Locations

1 site across 1 country: United States