Central Nervous System Tumor
Conditions
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
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).
Interventions
DRUGtozuleristide
tozuleristide 24 or 36 mg administered intravenously 1-24 hours prior to surgery
DEVICECanvas imaging system
imaging device attached to surgical microscope
PROCEDURESurgical resection of tumor
Standard of care surgical resection of tumor
Sponsors
John Yu
Blaze Bioscience Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Yu, MD
Cedars-Sinai Medical Center
Participant flow
Recruitment details
The trial opened to accrual on 9/27/2021 with first subject enrolled on study 9/30/2021. A total of 56 patients consented; 6 subjects failed screening; 50 subjects were enrolled/went on study/on treatment, 46 completed study intervention, and 45 were deemed evaluable. The last subject went off treatment on 3/5/2025. Last data collection for primary endpoint confirmed on 3/6/2025 as the primary completion date. 0 subjects are in follow-up.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 59.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 8 | 0 / 4 |
| other Total, other adverse events | 31 / 38 | 6 / 8 | 4 / 4 |
| serious Total, serious adverse events | 5 / 38 | 2 / 8 | 1 / 4 |
Outcome results
None listed