Sentinel Lymph Node Mapping Post-Injection Site Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02065232|
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : July 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Tilmanocept Drug: Sulfur Colloid||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-blinded, Controlled Clinical Trial Comparing Post-injection Site Pain of Technetium-labeled Tilmanocept Versus Technetium-labeled Sulfur Colloid in Patients Undergoing Sentinel Lymph Node Mapping Procedure for Breast Cancer|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Active Comparator: Tilmanocept
Patients will receive technetium-labeled tilmanocept, which is FDA approved for sentinel lymph node mapping in breast cancer.
Other Name: Lymphoseek
Active Comparator: Sulfur Colloid
Patients will receive technetium-labeled sulfur colloid, which is FDA approved for sentinel lymph node mapping in breast cancer.
|Drug: Sulfur Colloid|
- Change from baseline level of discomfort [ Time Frame: 1,2,3,4,5,15, 30 minutes after injection ]After injection of either tilmanocept or sulfur colloid, patients will be asked to fill out a pain questionnaire at the above time points.
- Visualization of Sentinel Lymph Nodes on Lymphoscintigraphy [ Time Frame: 15,30,60 minutes after injection ]After injection of sulfur colloid or tilmanocept, patients will undergo lymphoscintigraphy imaging (as is standard of care for sentinel lymph node mapping) at 5, 30, and 60 minutes. We will analyze the time it takes for sentinel lymph nodes to appear on these images comparing tilmanocept versus sulfur colloid.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065232
|United States, California|
|University of California, San Diego|
|San Diego, California, United States, 92093|