Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In addition, in some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time, as they operate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Number of participants with adverse events
Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.
Time frame: Within at least 1 week from baseline
Change in concentration of BLZ-100 in the blood
BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
Time frame: Prior to dosing and 1, 5, 15, 30, 60 and 90 minutes and 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Determination of a dose level for Phase 2 studies
Time frame: At end of study - approximately 14 months
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