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

Recruiting in Palo Alto (17 mi)

Overseen byJohn Yu, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: John Yu

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the use of tozuleristide and the Canvas imaging system during surgical resection of primary central nervous system tumors, to identify which tumor types demonstrate detectable fluorescence following administration of 24 mg tozuleristide and imaged with the Canvas imaging system during surgical resection, and, among tumors that demonstrate 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 residual fluorescence at the time of surgery corresponds to residual 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).

Research Team

John Yu, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

Inclusion Criteria

An MRI obtained within 30 days of study enrollment documents a lesion that is likely to be a primary cancerous tumor in the central nervous system

Subjects who have received prior therapy are eligible for the study as long as they have recovered from any harmful effects of the prior therapy and there is enough time before they enroll in the study.

Adequate renal and liver function