drugset / Trial / NCT02589366

Lymphoseek as Lymphoid Tissue Targeting Agent in Patients With Cancer of the Endometrium

NCT02589366

NaSingle-groupOpen-labelTreatment

Summary

Part of standard treatment for endometrial cancer is to remove one or more groups of lymph nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the body throughout the lymphatic system (the tissues and organs involved in immunity, which aids in the fight against infection and cancer). The purpose of this study is to compare the safety and ability of Lymphoseek and a Vital Blue Dye (tracing agent) to find lymph nodes that may carry cancer from the tumor through the lymphatic system. Lymphoseek will be injected into the tumor on the day before surgery to remove lymph nodes. Vital Blue Dye will be administered during surgery to trace the cancer as well. The surgeon will remove the lymph nodes as part of routine surgery and will keep track of which lymph nodes are identified by Lymphoseek and Vital Blue Dye. These nodes will be sent to another doctor to view them under a microscope and see if the nodes contain cancer cells. The hypothesis is that Lymphoseek can be used safely and will be at least as effective as blue dye in identifying the lymph nodes that may have cancer cells.

Timeline

Start
2015-11
Primary completion
2018-04
Completion
2018-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Technetium Tc 99m Tilmanocept Diagnostic / imaging agent 50 ug Other
Subject Vital Blue Dye Diagnostic / imaging agent

Indications