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

Not Recruiting

Trial ID: NCT04511026

Purpose

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.

Official Title

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

Stanford Investigator(s)

Amer Karam
Amer Karam

Clinical Professor, Obstetrics & Gynecology - Gynecologic Oncology

Eligibility


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.

Intervention(s):

drug: Lymphoseek

device: Single Photon Emission Computed Tomography (SPECT)

drug: Indocyanine Green (ICG)

device: Neoprobe Gamma Detection System NPB11L(Model1102)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sujatha Kalle
650-724-3308

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