Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Lymphoseek
  • Device: Single Photon Emission Computed Tomography (SPECT)
  • Drug: Indocyanine Green (ICG)
  • Device: Neoprobe Gamma Detection System NPB11L(Model1102)

Phase:

Phase 2

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nimna Ranatunga
650-721-4070