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

Central Nervous System Tumor Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Tumor
• Nervous System Neoplasms

• NCT number: NCT04743310
• Study type: Interventional
• Source: Cedars-Sinai Medical Center
• Contact: Clinical Trial Navigator
• Phone: 310-423-2133
• Email: cancer.trial.info@cshs.org
• Status: Recruiting
• Phase: Phase 2
• Start date: September 30, 2021
• Completion date: November 2024