Lymphoseek as Lymphoid Tissue Targeting Agent in Patients With Cancer of the Endometrium
Status:
Terminated
Trial end date:
2018-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
University of California, San Diego
Collaborators:
Cardinal Health 414, LLC Navidea Biopharmaceuticals