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

Central Nervous System Tumor Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04743310
• Other study ID #: IIT2020-09-Yu-BBIST001
• Status: Recruiting
• Phase: Phase 2
• Start date: September 30, 2021
• Est. completion date: November 2024

Study information

• Verified date: August 2023
• Source: Cedars-Sinai Medical Center
• Contact: Clinical Trial Navigator
• Phone: 310-423-2133
• Email: cancer.trial.info[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Tumor
• Nervous System Neoplasms

Intervention

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

Device:
• Canvas imaging system
imaging device attached to surgical microscope

Procedure:
• Surgical resection of tumor
Standard of care surgical resection of tumor

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
John Yu	Blaze Bioscience Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Percentage of patients with fluorescence-positive primary tumor biopsy		At the time of surgery
Primary	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
Primary	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	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
Secondary	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
Secondary	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