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Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
Trial ID: NCT04511026
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.
Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study
- The patient has histological diagnosis of cancer of the endometrium of any histology
- 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
- 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
- The patient has an iodine allergy.
- The patient is pregnant or lactating.
device: Single Photon Emission Computed Tomography (SPECT)
drug: Indocyanine Green (ICG)
device: Neoprobe Gamma Detection System NPB11L(Model1102)
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