Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Endometrial Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/2/2016 |
| Start Date: | September 2012 |
| End Date: | January 2015 |
| Contact: | Robert W Holloway, M.D. |
| Email: | robhollowaymd@gmail.com |
| Phone: | 407-303-2422 |
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
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.
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.
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 hematoxolin and eosin (H&E) results.
[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 hematoxolin and eosin (H&E) results.
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)
We found this trial at
1
site
Click here to add this to my saved trials
