Status:
TERMINATED
Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
Lead Sponsor:
Stanford University
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 det...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04511026
Start Date
January 20 2021
End Date
June 10 2021
Last Update
October 11 2023
Active Locations (1)
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1
Stanford University, School of Medicine
Stanford, California, United States, 94304