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

NCT ID: NCT04743310

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2025-03-06

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tozuleristide with Canvas imaging system

Group Type: EXPERIMENTAL

tozuleristide

Intervention Type: DRUG

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

Canvas imaging system

Intervention Type: DEVICE

imaging device attached to surgical microscope

Surgical resection of tumor

Intervention Type: PROCEDURE

Standard of care surgical resection of tumor

Interventions

tozuleristide

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

Intervention Type: DRUG

Canvas imaging system

imaging device attached to surgical microscope

Intervention Type: DEVICE

Surgical resection of tumor

Standard of care surgical resection of tumor

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blaze Bioscience Inc.

INDUSTRY

Sponsor Role: collaborator

John Yu

OTHER

Sponsor Role: lead

Responsible Party

John Yu

Director, Surgical Neuro-Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2020-09-Yu-BBIST001

Identifier Type: -

Identifier Source: org_study_id