Clinical trial NCT04743310: Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Blaze Bioscience Inc.
First posted: 2021-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of patients with fluorescence-positive primary tumor biopsy
timeFrame: At the time of surgery
measure: True positive rate of fluorescence, defined as the percentage of tumor-positive and fluorescence-positive tissue biopsies among all tumor-positive tissue biopsies
timeFrame: At the time of surgery
measure: True negative rate of fluorescence, defined as the percentage of tumor-negative and fluorescence-negative tissue biopsies among all tumor-negative tissue biopsies
timeFrame: At the time of surgery
Secondary outcomes:
measure: Positive predictive value of fluorescence, defined as the percentage of tumor-positive and fluorescence-positive tissue biopsies among all fluorescence-positive tissue biopsies
timeFrame: At the time of surgery
measure: Negative predictive value of fluorescence, defined as the percentage of tumor-negative and fluorescence-negative tissue biopsies among all fluorescence-negative tissue biopsies
timeFrame: At the time of surgery
measure: 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
timeFrame: At the time of surgery
Other outcomes:
measure: Incidence of adverse events
timeFrame: 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
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: John Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: