CLINICAL TRIALS PROFILE FOR TECHNETIUM TC-99M TILMANOCEPT

All Clinical Trials for technetium tc-99m tilmanocept

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01902953 ↗	Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC)	Completed	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		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		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.
NCT02201420 ↗	Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT	Completed	Navidea Biopharmaceuticals	Phase 2	2014-09-01	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.

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
Kaposi's Sarcoma	1
Liver Metastases	1
Melanoma	1

Condition MeSH

Condition MeSH for technetium tc-99m tilmanocept
Intervention	Trials
Carcinoma	1
Head and Neck Neoplasms	1
Colonic Neoplasms	1
Endometrial Neoplasms	1

Clinical Trial Locations for technetium tc-99m tilmanocept

Trials by Country

Trials by Country for technetium tc-99m tilmanocept
Location	Trials
United States	6
Switzerland	1

Trials by US State

Trials by US State for technetium tc-99m tilmanocept
Location	Trials
California	4
Alabama	1
New York	1

Clinical Trial Progress for technetium tc-99m tilmanocept

Clinical Trial Phase

Clinical Trial Phase for technetium tc-99m tilmanocept
Clinical Trial Phase	Trials
Phase 2	3
Phase 1	2
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for technetium tc-99m tilmanocept
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Suspended	1

Clinical Trial Sponsors for technetium tc-99m tilmanocept

Sponsor Name

Sponsor Name for technetium tc-99m tilmanocept
Sponsor	Trials
Navidea Biopharmaceuticals	4
University of California, San Diego	2
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for technetium tc-99m tilmanocept
Sponsor	Trials
Other	5
Industry	5
NIH	3