Cathepsin Activatable Fluorescent Probe (LUM015)
Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are examined to see if cancer cells are present. This may take a few to several days. Patients tissue with positive (cancer cells present) margins may require additional therapies including surgery. The purpose of this study is to determine a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that will show in the tumor area during surgery and may help facilitate visualization of tumor for its removal.
|Study Design:||Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015|
- Dose of LUM015 in mg [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Dose of LUM015 in mg that is tolerated and labels tumors
- Mean number of fluorescence counts per second per square centimeter [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
- To obtain PK/PD information regarding LUM015 when administered IV in patients. [ Time Frame: Two years ] [ Designated as safety issue: No ]The pharmacokinetic parameters to be measured will include: area under the curve (AUCt), maximum concentration (Cmax), time to maximum concentration (tmax) and first-order terminal (elimination) rate constant. Secondary (derived) parameters will include: terminal half-life (t1/2), clearance (CL), mean residence time (MRT), and apparent volume of distribution during the terminal phase (Vz). The distribution of these parameters will be described for each dose cohort separately; breast and sarcoma patients will be combined.
- To analyze cathepsin protease expression in tumors. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Cathepsin expression in tumors, measured in arbitrary units by Real-Time PCR compared to adjacent normal tissue when available, will be assessed in sarcomas and breast tumors. For each tissue specimen the expression of cathepsin will be compared to the imaging signal. Scatterplots of cathepsin level against imaging signal will be made according to tissue type within each dose cohort.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Receive single dose of LUM015 through a vein in the arm the day prior to surgery
LUM015 assigned dose given once by IV push
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626066
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Brian Brigman, MD||Duke University|