CLINICAL TRIALS PROFILE FOR LYMPHOSEEK KIT
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All Clinical Trials for LYMPHOSEEK KIT
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00671918 ↗ | 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. |
| NCT00911326 ↗ | 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. |
| NCT01106040 ↗ | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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