Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma
Completed
Navidea Biopharmaceuticals
Phase 3
2008-04-01
Data from this pivotal clinical trial will be used to support a marketing application (i.e.,
NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes)
in the lymphatic pathway draining the primary site of a tumor.
Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
Terminated
Navidea Biopharmaceuticals
Phase 3
2009-05-01
The purpose of this study is to determine the false negative rate (FNR) associated with
Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of
non-sentinel lymph nodes in elective neck dissection (END) in head & neck squamous cell
carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement
NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or
melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent
to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic
pathway draining the primary site of a tumor.
Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes
Completed
Navidea Biopharmaceuticals
Phase 3
2010-06-01
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.
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