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Last Updated: October 18, 2019

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CLINICAL TRIALS PROFILE FOR LYMPHOSEEK KIT

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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.
NCT01902953 Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC) Active, not recruiting Maimonides Medical Center Phase 2 2013-03-01 45 patients undergoing a colon (large bowel/intestine)removal operation for the diagnosis of colon cancer will be included in this study. During colon operation the affected portion of the colon is removed. In addition, lymph nodes are included in the specimen and evaluated by a pathologist. Analysis of the lymph nodes in the specimen are important because this is an important aspect of determining the stage of the cancer. Once the standard technique is used for the colon removal operation and the specimen is removed it will be injected with two drugs to help identify the lymph nodes. One is a blue dye and the other a radiotracer. The colon and ALL of the lymph nodes will then be sent for the standard pathologic evaluation. The patient themselves will never be injected with these drugs being used for research. Following the standard lymph node evaluation, an additional pathologist at an outside research facility will further examine the lymph nodes in the specimen using more in depth techniques which are above and beyond the standard of care. The results of all the pathologic tests will be conveyed to the surgeon of record to help in their decision making regarding further treatment. The study hypothesis is that radiotracer will be at least as effective as blue dye in identifying the lymph nodes most likely to harbor cancer cells (sentinel nodes). Once identified, these sentinel nodes can then undergo a more in depth review leading to improved staging of colorectal cancer and more accurate treatment.
NCT02065232 Sentinel Lymph Node Mapping Post-Injection Site Pain Completed Navidea Biopharmaceuticals Phase 4 2014-03-01 This is a pain survey study that will compare the level of discomfort experienced by breast cancer patients after injection of either technetium-labeled sulfur colloid or technetium-labeled tilmanocept, both FDA-approved agents used for sentinel lymph node biopsy (SLNB). Breast cancer patients who are already scheduled for SLNB as part of their original surgical plan will be asked to participate in this study and be randomized to receive either technetium-labeled sulfur colloid or technetium-labeled tilmanocept. After injection, patients will complete pain questionnaires to measure the amount of discomfort they are feeling during and after they receive the injection. There will be no change to the patient's treatment plan other than the addition of pain questionnaires. The investigators' hypothesis is that patients will feel less discomfort after injection of tilmanocept versus sulfur colloid.
NCT02065232 Sentinel Lymph Node Mapping Post-Injection Site Pain Completed University of California, San Diego Phase 4 2014-03-01 This is a pain survey study that will compare the level of discomfort experienced by breast cancer patients after injection of either technetium-labeled sulfur colloid or technetium-labeled tilmanocept, both FDA-approved agents used for sentinel lymph node biopsy (SLNB). Breast cancer patients who are already scheduled for SLNB as part of their original surgical plan will be asked to participate in this study and be randomized to receive either technetium-labeled sulfur colloid or technetium-labeled tilmanocept. After injection, patients will complete pain questionnaires to measure the amount of discomfort they are feeling during and after they receive the injection. There will be no change to the patient's treatment plan other than the addition of pain questionnaires. The investigators' hypothesis is that patients will feel less discomfort after injection of tilmanocept versus sulfur colloid.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lymphoseek Kit

Condition Name

Condition Name for Lymphoseek Kit
Intervention Trials
Breast Cancer 4
Melanoma 3
Rheumatoid Arthritis 3
Rectal Cancer 1
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Condition MeSH

Condition MeSH for Lymphoseek Kit
Intervention Trials
Breast Neoplasms 4
Arthritis, Rheumatoid 3
Melanoma 3
Carcinoma 2
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Clinical Trial Locations for Lymphoseek Kit

Trials by Country

Trials by Country for Lymphoseek Kit
Location Trials
United States 37
Israel 1
United Kingdom 1
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Trials by US State

Trials by US State for Lymphoseek Kit
Location Trials
California 9
Ohio 6
Florida 5
Alabama 4
Pennsylvania 3
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Clinical Trial Progress for Lymphoseek Kit

Clinical Trial Phase

Clinical Trial Phase for Lymphoseek Kit
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Lymphoseek Kit
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 5
Completed 5
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Clinical Trial Sponsors for Lymphoseek Kit

Sponsor Name

Sponsor Name for Lymphoseek Kit
Sponsor Trials
Navidea Biopharmaceuticals 15
National Cancer Institute (NCI) 3
University of California, San Diego 2
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Sponsor Type

Sponsor Type for Lymphoseek Kit
Sponsor Trials
Industry 15
Other 6
NIH 5
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