Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce additional surgical dissection that is needed in case a sentinel lymph node cannot be detected.

Detailed Description
-----------------
Primary Objective: To determine the detection rate of bilateral sentinel lymph nodes with the concurrent use of Lymphoseek and Indocyanine Green. Secondary Objective: (1) To determine the overall detection rate of sentinel lymph nodes with concurrent use of Lymphoseek and Indocyanine Green (2) To determine location and number of Lymphoseek-positive sentinel lymph nodes preoperatively by single-photon emission computed tomography (SPECT/CT imaging) and intraoperatively by a laparoscopic handheld gamma detection device and near- infrared fluorescent imaging (3) To determine the concordance of Lymphoseek-positive sentinel lymph nodes with intraoperatively detected Indocyanine Green-positive sentinel lymph nodes.

Official Title
-----------------
Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Drug: Lymphoseek
* Device: Single Photon Emission Computed Tomography (SPECT)
* Drug: Indocyanine Green (ICG)
* Device: Neoprobe Gamma Detection System NPB11L(Model1102)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has histological diagnosis of cancer of the endometrium of any histology or grade. The patient should have received no prior treatment for her endometrial cancer. The patient has clinically uterine confined disease. The patient is a candidate for minimal invasive surgery, with sentinel lymph node assessment with IC-GREEN planned as part of standard of care. The patient has an Eastern Cooperative Group (ECOG) performance status of 0-2. If age less than or equal to 55 years, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year. The patient has provided written informed consent. The patient is at least 18 years of age at the time of consent Exclusion Criteria: The patient has clinical or radiological evidence of metastatic disease. The patient has a history of a prior loop electrosurgical excision procedure (LEEP) or cone procedure performed on her cervix. The patient has participated in another investigational drug study within 30 days of scheduled surgery. The patient has an iodine allergy. The patient is pregnant or lactating.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lymphoseek/SPECT-CT/Indocyanine<br>The subject will receive f 0.5 mL each Lymphoseek into the uterine cervix prior to surgery and subsequent SPECT/CT imaging preoperatively. Intraoperatively, following anesthesia induction, Indocyanine Green (0.5 mL) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery. | Drug: Lymphoseek<br>* Radioactive diagnostic agent<br>* Other names: technetium Tc 99m tilmanocept;Device: Single Photon Emission Computed Tomography (SPECT)<br>* Imaging test<br>Drug: Indocyanine Green (ICG)<br>* Cyanine dye used in medical diagnostics manufactured by Akorn Inc.<br>Device: Neoprobe Gamma Detection System NPB11L(Model1102)<br>* Neoprobe Gamma Detection System NPB11L(Model1102) made by Devicor Medical Products, Inc.<br>* Other names: Laparoscopic handheld gamma counter;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Bilateral SLNs | A sentinel lymph node will be defined as being detected if it is detected on the pre-operative SPECT/CT imaging scan or intraoperatively using near-infrared imaging or the handheld gamma detection device. | during surgery, an average of 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Detection of SLN Detection | For each subject, an assessment will be made of whether there was overall sentinel node detection. A sentinel lymph node will be defined as being detected if it is detected on the pre-operative SPECT/CT imaging scan or intraoperatively using near-infrared imaging or the handheld gamma detection device. If at least one SLN is detected (on any side), then this outcome will be considered a 'Yes'. | during surgery, an average of 3 hours | 
| Number of SLNs Detected by Lymphoseek: | The number of sentinel lymph nodes detected by Lymphoseek will be assessed. A sentinel lymph node will be defined as being detected by Lymphoseek if it is detected using the pre-operative SPECT/CT imaging scan and/or intraoperatively using the gamma detection device. | during surgery, an average of 3 hours | 
| Location of SLNs Detected by Lymphoseek: | The location and number of sentinel lymph nodes detected by Lymphoseek will be assessed. A sentinel lymph node will be defined as being detected by Lymphoseek if it is detected using the pre-operative SPECT/CT imaging scan and/or intraoperatively using the gamma detection device. | during surgery, an average of 3 hours | 
| Number of SLNs Detected by Indocyanine Green | Number of SLNs detected by Indocyanine Green: The location and number of sentinel lymph nodes detected by Indocyanine Green will be assessed. A sentinel lymph node will be defined as being detected by Indocyanine Green if it is detected intraoperatively using near-infrared imaging only and not by the gamma detection device. | during surgery, an average of 3 hours | 
| Location of SLNs Detected by Indocyanine Green | Location of SLNs detected by Indocyanine Green: The location and number of sentinel lymph nodes detected by Indocyanine Green will be assessed. A sentinel lymph node will be defined as being detected by Indocyanine Green if it is detected intraoperatively using near-infrared imaging only and not by the gamma detection device. | during surgery, an average of 3 hours |