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

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

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.

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.

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.