Clinical trial NCT02068820: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: Sentinel lymph nodes
da Vinci
Firefly
Sentinel lymph node mapping
Fluorescence Imaging
SLN
SLN mapping
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.
timeFrame: through 6 weeks post-operative
Secondary outcomes:
measure: Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.
timeFrame: through 6 weeks post-operative
Other outcomes:
measure: Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).
timeFrame: through 6 weeks post-operative
Locations:
city: Orlando
country: United States
facility: Florida Hospital Gynecologic Oncology
state: Florida
Study officials:
affiliation: Florida Hospital Gynecologic Oncology
name: Robert Holloway, MD
role: PRINCIPAL_INVESTIGATOR
References: