Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes
Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
Data from this pivotal clinical trial will be used to support a marketing application (i.e.,
NDA) of Navidea's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in
the lymphatic pathway draining the primary site of a tumor.
Multicenter, open-label, within-patient comparative study of Lymphoseek and vital blue dye in
the detection of excised lymph nodes in patients with known melanoma and breast cancer. All
patients will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc
99m and vital blue dye.