This phase IIa trial studies how well technetium Tc 99m-labeled tilmanocept (Lymphoseek) and isosulfan blue (vital blue dye) work in detecting lymph nodes in patients with endometrial cancer who are undergoing lymph node dissection. Lymphoseek, a radioactive tracing agent and vital blue dye tracing agent, may be able to identify lymph nodes that carry cancer from the tumor through the body.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02589366.
PRIMARY OBJECTIVE:
I. To determine the radiation absorbed dose to target organs or tissues, incidence of adverse events, changes over time in vital signs, clinical laboratory parameters, and physical examination findings.
II. To determine the average number of lymph nodes detected with Lymphoseek intraoperatively as determined with a laparoscopic hand held gamma detection device and the average number of nodes detected with preoperative whole body scan and single photon emission computed tomography (SPECT)/computed tomography (CT).
SECONDARY OBJECTIVES:
I. To determine the proportion of lymph nodes identified intraoperatively by vital blue dye that are also identified intraoperatively by Lymphoseek.
OUTLINE:
Patients receive Lymphoseek peritumorally on day 0. Within 1-2 hours after the Lymphoseek injection, patients undergo SPECT/CT scans and a whole body scan. Beginning 14 to 20 hours after the injection of Lymphoseek, patients receive isosulfan blue on day 1 and undergo sentinel lymph node mapping by laparoscopic visualization and handheld gamma detector. Patients then undergo standard lymph node dissection.
After completion of study treatment, patients are followed up once on days 8-15.
Lead OrganizationUC San Diego Medical Center - Hillcrest
Principal InvestigatorMichael T. McHale
