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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR TECHNETIUM TC-99M TILMANOCEPT

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Clinical Trials for Technetium Tc-99m Tilmanocept

Trial ID Title Status Sponsor Phase Summary
NCT01902953 Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC) Active, not recruiting Maimonides Medical Center Phase 2 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 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 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.
NCT02201420 Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT Completed Navidea Biopharmaceuticals Phase 2 The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This is a single center, open-label, within-subject study.
NCT02589366 Lymphoseek as Lymphoid Tissue Targeting Agent in Patients With Cancer of the Endometrium Recruiting Navidea Biopharmaceuticals Phase 1 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Technetium Tc-99m Tilmanocept

Condition Name

Condition Name for Technetium Tc-99m Tilmanocept
Intervention Trials
Head and Neck Squamous Cell Carcinoma 1
Endometrial Cancer 1
Colorectal Carcinoma 1
Colon Cancer 1
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Condition MeSH

Condition MeSH for Technetium Tc-99m Tilmanocept
Intervention Trials
Endometrial Neoplasms 1
Carcinoma, Squamous Cell 1
Skin Neoplasms 1
Neoplasms, Second Primary 1
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Clinical Trial Locations for Technetium Tc-99m Tilmanocept

Trials by Country

Trials by Country for Technetium Tc-99m Tilmanocept
Location Trials
United States 6
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Trials by US State

Trials by US State for Technetium Tc-99m Tilmanocept
Location Trials
California 4
Alabama 1
New York 1
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Clinical Trial Progress for Technetium Tc-99m Tilmanocept

Clinical Trial Phase

Clinical Trial Phase for Technetium Tc-99m Tilmanocept
Clinical Trial Phase Trials
Phase 4 1
Phase 2 3
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Technetium Tc-99m Tilmanocept
Clinical Trial Phase Trials
Active, not recruiting 2
Completed 2
Recruiting 1
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Clinical Trial Sponsors for Technetium Tc-99m Tilmanocept

Sponsor Name

Sponsor Name for Technetium Tc-99m Tilmanocept
Sponsor Trials
Navidea Biopharmaceuticals 4
National Cancer Institute (NCI) 2
University of California, San Diego 2
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Sponsor Type

Sponsor Type for Technetium Tc-99m Tilmanocept
Sponsor Trials
Industry 4
Other 4
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Covington
Teva
Cipla
Cantor Fitzgerald
Mallinckrodt
Deloitte
Argus Health
Merck

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