Spots Global Cancer Trial Database for Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas
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Trial Identification
Brief Title: Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas
Official Title: Performance of Elucirem® (Gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Perfusion of Brain Gliomas Phase IIIb Clinical Trial
Study ID: NCT06057168
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá, Budapest, , Hungary
Semmelweis Egyetem - Neurologiai Klinika, Budapest, , Hungary
Debreceni Egyetem, Debrecen, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs, , Hungary
Ospedale Papa Giovanni XXIII, Bergamo, , Italy
Ospedale San Raffaele- Neuroradiologia, Milano, , Italy
IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione, Pavia, , Italy
Policlinico Universitario Agostino Gemelli, Roma, , Italy
Uniwersyteckie Centrum Kliniczne w Gdansku, Gdańsk, , Poland
Szpital Specjalistyczny im.L.Rydygiera, Kraków, , Poland
Independent Public Teaching Hospital no 1 Department of Interventional Radiology and Diagnostic Imaging, Lublin, , Poland
Contact Details
Name: Frantz Hebert
Affiliation: Guerbet
Role: STUDY_DIRECTOR
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