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NCT Number: NCT04743310

Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and 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).

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Key information

Conditions

Central Nervous System Tumor Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cranial Nerve Diseases Cranial Nerve Neoplasms Craniopharyngioma Ear Diseases Ependymoma Glioblastoma Glioma Medulloblastoma Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neurilemmoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroendocrine Tumors Neuroma Neuroma, Acoustic Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Peripheral Nervous System Neoplasms Pinealoma Retrocochlear Diseases Spinal Cord Diseases Spinal Cord Neoplasms Vestibulocochlear Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tozuleristide

Drug

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

Canvas imaging system

Device

imaging device attached to surgical microscope

Surgical resection of tumor

Procedure

Standard of care surgical resection of tumor

Primary outcomes

  1. Percentage of Patients With Fluorescence-positive Primary Tumor Biopsy

    Time frame: At the time of surgery

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

    Time frame: At the time of surgery

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

    Time frame: At the time of surgery

Secondary outcomes

  1. Positive Predictive Value of Fluorescence, Defined as the Percentage of Tumor-positive and Fluorescence-positive Tissue Biopsies Among All Fluorescence-positive Tissue Biopsies

    Time frame: At the time of surgery

  2. Negative Predictive Value of Fluorescence, Defined as the Percentage of Tumor-negative and Fluorescence-negative Tissue Biopsies Among All Fluorescence-negative Tissue Biopsies

    Time frame: At the time of surgery

  3. 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

    Time frame: At the time of surgery

    To preliminarily 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 MRI. This measure reports the number of participants that met the criteria for each extent of resection category based on post-operate MRI findings. In order from best to worst in terms of extent of resection: Gross total resection means no residual gadolinium enhancing tumor on postoperative MRI, Near gross total resection means minimal residual gadolinium enhancing tumor on MRI, less than 0.5 cm cubed, Subtotal resection means residual gadolinium enhancing tumor noted on post operative MRI, and Biopsy only means residual tumor from a biopsy only of the tumor.

Other outcomes

  1. Incidence of Adverse Events

    Time frame: 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

    Recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5

Sponsors and collaborators

Lead sponsor

John Yu

Other

Collaborators

  • Blaze Bioscience Inc.

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2021
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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