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 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. The investigators 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. This is a safety study to assess the safety of BLZ-100 in pediatric patients with central nervous system tumors.
Subjects who provide voluntary written informed consent, or have it provided by their legally acceptable representative, will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate. Subjects will be required to arrive at the hospital for dosing at least 1 hour before the planned surgical excision. Following dosing, subjects will be monitored for safety and surgical excision will occur at least 1 hour after study product administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
29
Seattle Children's
Seattle, Washington, United States
Number of participants with adverse events
Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.
Time frame: Seven days after study drug administration
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 at 10 minutes, 30 minutes, and 60 minutes post BLZ-100 administration
Fluorescence signal in excised central nervous system tumors
Fluorescence signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.
Time frame: At least 1 hour post-dose
Extent of resection (expansion cohort only)
For subjects enrolled in the expansion cohort, an extent of resection assessment will be made by the surgeon and confirmed by post-operative MRI according to standard of care procedures.
Time frame: At completion of surgery for surgeon assessment and up to 1 week after surgery for MRI assessment
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