Central Nervous System TumorPhase 2NCT04743310
Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System
A Phase 2 study testing tozuleristide, Canvas imaging system and Surgical resection of tumor in people with Central Nervous System Tumor, run by John Yu at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Tumor
- What is being tested?
- tozuleristide, Canvas imaging system and Surgical resection of tumor
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 6 Mar 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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
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
- Being tested
- tozuleristide, Canvas imaging system, Surgical resection of 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
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Spinal Cord Neoplasms, Glioma, Astrocytoma, Glioblastoma, Ependymoma, Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tozuleristideDrug
tozuleristide 24 or 36 mg administered intravenously 1-24 hours prior to surgery
Canvas imaging systemDevice
imaging device attached to surgical microscope
Surgical resection of tumorProcedure or surgery
Standard of care surgical resection of tumor
| Study group | Role | What they receive |
|---|---|---|
| Tozuleristide with Canvas imaging system | Experimental | Not described Receives: Drug: tozuleristide; Device: Canvas imaging system; Procedure: Surgical resection of tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Fluorescence-positive Primary Tumor Biopsy
Measured: 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
Measured: 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
Measured: At the time of surgery
Secondary outcomes (3)
Positive Predictive Value of Fluorescence, Defined as the Percentage of Tumor-positive and Fluorescence-positive Tissue Biopsies Among All Fluorescence-positive Tissue Biopsies
Measured: 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
Measured: 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
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.
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start30 Sep 2021
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Yu
- Sponsor type
- University, hospital or other
- Collaborators
- Blaze Bioscience Inc.
- Responsible party
- Sponsor-investigator, John Yu, Cedars-Sinai Medical Center
- Investigators
- John Yu, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743310
- Sponsor's protocol ID
- IIT2020-09-Yu-BBIST001
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2021
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fox RC, Fan X, Mamelak AN, Gomez D, Patil C, Chu RM, Rudnick J, Hu J, Sina EM, Black KL, Harrington K, Yu JS. Tozuleristide Fluorescence-Guided Resection of Gliomas: Results of a Phase II Investigator-Initiated Study. Oper Neurosurg. 2026 Sep 25. doi: 10.1227/ons.0000000000002203. Online ahead of print.
PubMed 42788739