Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 9:31 PM
Study NCT ID:
NCT06057168
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2023-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas
Sponsor:
Guerbet
Organization:
Study Overview
Official Title:
Performance of Elucirem® (Gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Perfusion of Brain Gliomas Phase IIIb Clinical Trial
Status:
COMPLETED
Status Verified Date:
2025-05
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:
GDX-44-016
Brief Summary:
This trial aims to study the performance of Elucirem® (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas.
Detailed Description:
The trial is designed as a prospective, multi-center, randomized, controlled and parallel group comparison.
This study aims to enrol 138 patients in Italy, Poland and Hungary.
During the course of the trial, patient will undergo a DSC-MRI perfusion using Elucirem® or Dotarem®. A safety visit will be performed 1 day after the MRI visit. Confirmation of tumor grade diagnosis, if available, will be collected up to 30 days after visit 2. Primary end point will be assessed by independent off-site blinded readers.
This study aims to enrol 138 patients in Italy, Poland and Hungary.
During the course of the trial, patient will undergo a DSC-MRI perfusion using Elucirem® or Dotarem®. A safety visit will be performed 1 day after the MRI visit. Confirmation of tumor grade diagnosis, if available, will be collected up to 30 days after visit 2. Primary end point will be assessed by independent off-site blinded readers.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: