Sentinel Lymph Node Mapping Post-Injection Site Pain
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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|
- Change from baseline level of discomfort [ Time Frame: 1,2,3,4,5,15, 30 minutes after injection ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02065232
|Contact: Anne Wallace, MDemail@example.com|
|Contact: Ava Hosseini, MDfirstname.lastname@example.org|
|United States, California|
|University of California, San Diego||Recruiting|
|San Diego, California, United States, 92093|
|Contact: Anne Wallace, MD email@example.com|