Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068820
• Other study ID #: SLN Mapping
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: January 2015

Study information

• Verified date: August 2019
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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.
• ICG dye and FireFly fluorescence imaging
Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.

Locations

Country	Name	City	State
United States	Florida Hospital Gynecologic Oncology	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).	Of the 127 positive nodes with pathology information, the percentage of each type of node will be summarized by the staining method. Statistical testing of the individual staining methods compared to both will be computed using Chi-square test of independence.	through 6 weeks post-operative
Primary	Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.		through 6 weeks post-operative
Secondary	Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.	The standard definition for negative predictive value was used to calculate NPV. There was one false negative SLN in this study, 39 true positive sentinel lymph nodes, and 140 negative pelvic metastatic patients.; NPV = 140/141=99.3%	through 6 weeks post-operative