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

NCT04743310 | Completed Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: IIT2020-09-Yu-BBIST001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Central Nervous System Tumor

Keywords

neurosurgery; brain tumor; spinal cord tumor; surgical resection; glioma; astrocytoma; glioblastoma; ependymoma; medulloblastoma; pineocytoma; meningioma; germ cell tumor; craniopharyngioma; oligoastrocytoma; pineoblastoma; extent of resection; maximal safe resection; neuropathology; vestibular schwannomas

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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 Outcomes (1)

• Incidence of adverse events

  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

Study Arms (1)

Tozuleristide with Canvas imaging system

EXPERIMENTAL

Drug: tozuleristide; Device: Canvas imaging system; Procedure: Surgical resection of tumor

Interventions

tozuleristide DRUG

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

Tozuleristide with Canvas imaging system

Canvas imaging system DEVICE

imaging device attached to surgical microscope

Tozuleristide with Canvas imaging system

Surgical resection of tumor PROCEDURE

Standard of care surgical resection of tumor

Tozuleristide with Canvas imaging system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• John Yu: lead
• Blaze Bioscience Inc.: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Spinal Cord Neoplasms; Glioma; Astrocytoma; Glioblastoma; Ependymoma; Medulloblastoma; Pinealoma; Meningioma; Neoplasms, Germ Cell and Embryonal; Craniopharyngioma; Neuroma, Acoustic

Interventions

tozuleristide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Neurilemmoma; Neuroendocrine Tumors; Neuroma; Nerve Sheath Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases

Study Officials

• John Yu, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Surgical Neuro-Oncology

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 8, 2021
• Study Start: September 30, 2021
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)