Canvas fluorescence imaging system characterization for intraoperative visualization of cancer cells with tozuleristide (BLZ-100) for a randomized, multi-center, phase 2/3 pediatric CNS tumor trial

Canvas^® imaging system development was motivated by a need to visualize concentrations of tozuleristide (BLZ-100) in vivo, while supporting a randomized, blinded, multi-center study in pediatric primary CNS tumor patients at U.S. pediatric hospitals. The trial was aimed at both assessing the safety and efficacy of tozuleristide and the safety and performance of the Canvas imaging system. This work presents the Canvas imaging system as an accessory for real-time, intraoperative tumor visualization using a Zeiss Pentero microscope and tozuleristide. In addition to tozuleristide, the Canvas imaging system is optimized for indocyanine green (ICG) or other imaging agents with similar absorption and fluorescence emission spectra. Details of the Canvas system design as an in vivo fluorescence imaging system, along with images from the clinical study are presented. The Canvas imaging system went through verification prior to release for the clinical trial and has also recently undergone characterization according to the AAPM task group report 311. This updated testing, as suggested by the AAPM includes: image sharpness, depth of field, signal uniformity, distortion, field of view, , signal sensitivity, limit of detection, linearity, dynamic range, and crosstalk. Due to the highly specialized use cases of each surgical indication, image data is presented and analyzed from clinical trials using tozuleristide.