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tozuleristide 24 or 36 mg administered intravenously 1-24 hours prior to surgery

tozuleristide

imaging device attached to surgical microscope

Canvas imaging system

Standard of care surgical resection of tumor

Surgical resection of tumor

Clinical Trial Navigator

Ray Chu, MD

Chirag Patil, MD

Jeremy Rudnick, MD

Jethro Hu, MD

Serguei Bannykh, MD, PhD

John Yu, MD

The purpose of this study is to examine the use of a single dose of tozuleristide (24 or 36 mg) and the Canvas imaging system during surgical resection of primary central nervous system (CNS) tumors: Primary gadolinium enhancing (high grade) CNS tumors, primary non-gadolinium enhancing CNS tumors, and primary vestibular schwannoma.

The primary objectives of the study is to see how well tozuleristide and the Canvas imaging system during surgical resection will show fluorescence among primary enhancing/high grade CNS tumors; and among the tumors that demonstrate tozuleristide fluorescence, to estimate the true positive rate and true negative rate of fluorescence in tissue biopsies, as well as sensitivity and specificity of tozuleristide fluorescence for distinguishing tumor from non-tumoral tissue.

The secondary objectives of the study include evaluating the safety of tozuleristide and the Canvas imaging system, and to determine if the presence of remaining fluorescence at the time of surgery corresponds to remaining tumor evident on post-operative MRI images, or if the absence of fluorescence corresponds to evidence of no gross residual tumor on post-operative magnetic resonance imaging (MRI).

Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System

A Phase 2 Study of Fluorescence Detection of Adult Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged With the Canvas System

Recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5

Blaze Bioscience Inc.

John Yu

Director, Surgical Neuro-Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System	NCT04743310	Central Nervous...	tozuleristide Canvas imaging ... Surgical resect...	18 Years -	Cedars-Sinai Medical Center
Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System	NCT04743310	Central Nervous...	tozuleristide Canvas imaging ... Surgical resect...	18 Years -	Cedars-Sinai Medical Center

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