NCT04743310CompletedPhase 2
Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System
A Phase 2 Study of Fluorescence Detection of Adult Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged With the Canvas System
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 4 Feb 2021
- Start date
- 30 Sept 2021
- Primary completion date
- 6 Mar 2025
- Lead sponsor
- John Yu
- Diseases
- Glioblastoma
- NCT number
- NCT04743310
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 50
- From 30 Sept 2021 to the primary completion date, 6 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Ongoing serious medical conditions such that participation in the study could put the subject at increased risk of worsening their condition
Other
- Pregnant, breast-feeding, or planning to conceive a child within 30 days
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
Related publications
- Tozuleristide Fluorescence-Guided Resection of Gliomas: Results of a Phase II Investigator-Initiated Study.Oper Neurosurg · 2026 · PMID 42788739
This page is information, not medical advice. Discuss any trial with your doctor.