Status:
COMPLETED
Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System
Lead Sponsor:
John Yu
Collaborating Sponsors:
Blaze Bioscience Inc.
Conditions:
Central Nervous System Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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: ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04743310
Start Date
September 30 2021
End Date
March 6 2025
Last Update
June 13 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048