NCT06057168

Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas

Performance of Elucirem (Gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Perfusion of Brain Gliomas Phase IIIb Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial aimed to study the performance of Elucirem (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas.

Detailed description

The trial was designed as a prospective, multi-center, randomized, controlled and parallel group comparison. This study aimed to enrol 138 patients in Italy, Poland and Hungary. During the course of the trial, patient underwent a DSC-MRI perfusion using Elucirem or Dotarem. A safety visit was performed 1 day after the MRI visit. Confirmation of tumor grade diagnosis, if available, was collected up to 30 days after visit 2. Primary end point was assessed by independent off-site blinded readers.

Conditions

• Brain Tumor, Primary
• Brain Tumor, Recurrent

Interventions

Type	Name	Description
DRUG	Elucirem	Intravenous administration
DRUG	Dotarem	Intravenous administration

Timeline

• Start date: 2023-09-07
• Primary completion: 2024-11-28
• Completion: 2024-11-28
• First posted: 2023-09-28
• Last updated: 2026-01-29
• Results posted: 2026-01-29

Locations

11 sites across 3 countries: Hungary, Italy, Poland