Brief Title
Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG
Official Title
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
Brief 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.
Study Type
Interventional
Primary Outcome
Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.
Secondary Outcome
Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.
Condition
Endometrial Cancer
Intervention
ISB dye and standard white light imaging
Study Arms / Comparison Groups
ISB dye, standard white light
Description: SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
200
Start Date
September 2012
Completion Date
January 2015
Primary Completion Date
January 2015
Eligibility Criteria
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)
Gender
Female
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Robert Holloway, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02068820
Organization ID
SLN Mapping
Responsible Party
Sponsor
Study Sponsor
AdventHealth
Study Sponsor
Robert Holloway, MD, Principal Investigator, Florida Hospital Gynecologic Oncology
Verification Date
August 2019