Study of Tozuleristide and the Canvas Imaging System in Pediatric Subjects With CNS Tumors Undergoing Surgery
Condition: Pediatric Central Nervous System Tumor
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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. Tozuleristide is a
      drug that is thought to attach to tumor tissue and then fluoresces (glows) when a special
      light from the Canvas is shined on it. It is hypothesized that tozuleristide, when imaged
      with the Canvas, will improve surgical outcomes by allowing surgeons to visualize the edges
      of the tumor or other ambiguous tissue in real-time as they operate. The purpose of this
      study is to evaluate how well tozuleristide imaged with Canvas work at helping to distinguish
      between tumor and normal tissue during surgery in pediatric primary central nervous system
      tumors.
    

Detailed description: 
      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.

      Surgical excision will occur at least 1 hour and no more than 36 hours after tozuleristide
      administration. Surgery will be performed by a neurosurgeon and the Canvas will be operated
      by a designated Imaging Operator. Fluorescence of tumor and ambiguous tissue during surgery
      will be assessed and scored. Biopsy samples of these tumor and ambiguous tissues will be
      collected for pathology analysis.

      All subjects will be monitored for safety during their participation in the study.
    

Intervention name(s): tozuleristide; Canvas System
Intervention type(s): Drug; Device
Intervention description(s): Tozuleristide will be administered at least 1 hour and no more than 36 hours prior to planned surgical excision of their tumor.; All subjects enrolled in the study will have their tissue imaged with the Canvas System.
Other intervention name(s): BLZ-100; Tumor Paint; mSIRIS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized 1:10 to 1 of 2 study arms. Subjects in arm 1 (~9% of subjects) will not receive tozuleristide but will undergo neurosurgery and imaging will be performed with the Canvas. Subjects in arm 2 (~91% of subjects) will receive tozuleristide and will undergo neurosurgery and imaging will be performed with the Canvas.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Tumor Paint; tozuleristide; Canvas imaging system; BLZ-100; CNS tumor; brain cancer; pediatrics; fluorescence guided surgery