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

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 2 Study of Fluorescence Detection of Adult Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged With the Canvas System

Conditions
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Central Nervous System Tumor

Intervention / Treatment
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* Drug: tozuleristide
* Device: Canvas imaging system
* Procedure: Surgical resection of tumor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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