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

Phase 2 Completed NCT04743310

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 ima

Percentage of Patients With Fluorescence-positive Primary Tumor Biopsy

At the time of surgery · percentage of participants

True Positive Rate of Fluorescence, Defined as the Percentage of Tumor-positive and Fluorescence-positive Tissue Biopsies Among All Tumor-positive Tissue Biopsies

At the time of surgery · % tumor+ & fluor + / Tumor+ biopsies

True Negative Rate of Fluorescence, Defined as the Percentage of Tumor-negative and Fluorescence-negative Tissue Biopsies Among All Tumor-negative Tissue Biopsies

At the time of surgery · % tumor- & fluor - /Tumor- biopsies

Open in BENITIONS View on ClinicalTrials.gov

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