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

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).

Study Overview

• Status: Completed
• Conditions: Central Nervous System Tumor
• Intervention / Treatment: Device: Canvas imaging system; Procedure: Surgical resection of tumor; Drug: tozuleristide

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• MRI obtained within 30 days of study enrollment documents a measurable lesion consistent with a primary malignant central nervous system tumor for which maximal safe resection is indicated OR MRI obtained within 30 days of study enrollment documents a measurable lesion consistent with a primary schwannoma enhancing tumor in the cerebellopontine angle for which maximal safe resection is indicated.
• Adequate renal and 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.

Exclusion Criteria:

• Pregnant, breast-feeding, or planning to conceive a child within 30 days
• Ongoing serious medical conditions such that participation in the study could put the subject at increased risk of worsening their condition
• Subjects planned to undergo only a diagnostic biopsy procedure, without intent to resect tissue for therapeutic purposes
• Subjects for whom radiographic evidence suggests a non-intra-axial primary brain tumor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tozuleristide with Canvas imaging system	Device: Canvas imaging system; imaging device attached to surgical microscope; Procedure: Surgical resection of tumor; Standard of care surgical resection of tumor; Drug: tozuleristide; tozuleristide 24 or 36 mg administered intravenously 1-24 hours prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with fluorescence-positive primary tumor biopsy	At the time of surgery
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Positive predictive value of fluorescence, defined as the percentage of tumor-positive and fluorescence-positive tissue biopsies among all fluorescence-positive tissue biopsies	At the time of surgery
Negative predictive value of fluorescence, defined as the percentage of tumor-negative and fluorescence-negative tissue biopsies among all fluorescence-negative tissue biopsies	At the time of surgery
Extent of residual tumor measured on post-operative magnetic resonance imaging scans among all patients with evidence of residual fluorescence at the time of surgery	At the time of surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5	From the time of study drug administration 1-24 hours prior to surgery, until 30 days after surgery or until receiving additional therapy for the central nervous system tumor, whichever comes first

Collaborators and Investigators

• Sponsor: John Yu
• Collaborators: Blaze Bioscience Inc.
• Investigators: Principal Investigator: John Yu, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): March 6, 2025
• Study Completion (Actual): March 6, 2025

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: glioma; glioblastoma; brain tumor; medulloblastoma; neurosurgery; ependymoma; oligoastrocytoma; pineoblastoma; surgical resection; astrocytoma; meningioma; germ cell tumor; craniopharyngioma; neuropathology; extent of resection; spinal cord tumor; pineocytoma; maximal safe resection; vestibular schwannomas
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: IIT2020-09-Yu-BBIST001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No