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

• Status: Suspended
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University

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.