Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743310
Status:
RECRUITING
Last Update Posted:
2023-08-31
First Post:
2021-02-04
Brief Title:
Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System
Sponsor:
John Yu
Organization:
Cedars-Sinai Medical Center
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 enhancinghigh 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
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 enhancinghigh 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None