This trial aimed to study the performance of Elucirem (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
138
Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá
Budapest, Hungary
Semmelweis Egyetem - Neurologiai Klinika
Budapest, Hungary
Debreceni Egyetem
Debrecen, Hungary
Diagnostic Quality of Cerebral Blood Volume (CBV) Map of Dynamic Susceptibility Contrast MRI (DSC-MRI) Perfusion
Diagnostic quality of the CBV map obtained from DSC-MRI perfusion for each patient was assessed by the two off-site blinded readers using the following scale (poor, fair, good or excellent) and by a consensus in case of discordance between the two readers. The proportion of patients with "excellent" or "good" diagnostic quality images of Elucirem group was compared to that of Dotarem group. 124 patients (60 with Elucirem and 64 with Dotarem) who had diagnostic CBV map and without major protocol deviation were included in the per-protocol primary analysis.
Time frame: From beginning to end of procedure for DSC-MRI perfusion using Elucirem or Dotarem
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Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary
Ospedale Papa Giovanni XXIII
Bergamo, Italy
Ospedale San Raffaele- Neuroradiologia
Milan, Italy
IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia, Italy
Policlinico Universitario Agostino Gemelli
Roma, Italy
Uniwersyteckie Centrum Kliniczne w Gdansku
Gdansk, Poland
Szpital Specjalistyczny im.L.Rydygiera
Krakow, Poland
...and 1 more locations