A Randomized, Blinded Study of Fluorescence Detection of Pediatric Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged with the Canvas System

The main goal of this efficacy study is to learn how well tozuleristide and the Canvas work at detecting tumors during surgery. This study will also look at the safety of using tozuleristide and the Canvas for surgery.

We want to find out how they make you feel and whether there are any side effects or changes to your laboratory results or vital signs. We will also investigate the images and pathology we get from the tissue samples removed during surgery.

Study procedures

Tozuleristide is an experimental drug that is given by injection into a vein. Tozuleristide is a man-made material that is thought to attach to tumor cells. It contains a dye that fluoresces, or glows, under a specific kind of light from an imaging camera called the Canvas system.

Surgeons often use a microscope for surgery and the Canvas attaches to it. The Canvas uses a special light that makes a drug like tozuleristide glow. The process of using the Canvas to shine light on tozuleristide to make it glow is called “fluorescence imaging”. It is sometimes difficult for surgeons to distinguish normal tissue from tumor tissue during surgery, or to see if the tumor has spread to other areas.

The goal of tozuleristide and the Canvas are to help surgeons to better see the difference between normal and tumor tissue during surgery using fluorescence imaging.

Eligibility

• Subjects must have MRI obtained within 30 days of study enrollment documenting a measurable lesion consistent with a pediatric primary CNS tumor for which maximal safe resection is indicated
• Adequate renal function
• Adequate liver function
• Subjects with prior therapy are eligible provided they have recovered from any acute toxic effects of prior therapy and have sufficient time interval prior to enrollment