Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417281
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-12
Brief Title:
Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid5-ALA
Sponsor:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd
Organization:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This trial is an open-label multicenter phase III clinical studyconducted in patients with newly diagnosed or recurrent malignant high-grade WHO grades 34 glioma to evaluate the efficacy and safety of a single oral dose of 5-aminolevulinic acid 5-ALA oral solution powder for fluorescence-guided tumor resection and photodynamic diagnosis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None