SAFETY AND EFFICACY EVALUATION OF DOTAREM® IN MAGNETIC RESONANCE IMAGING (MRI) IN PATIENTS WITH CENTRAL NERVOUS SYSTEM (CNS) LESIONS

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-020319-34

Femme et Homme

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Extrait

To demonstrate the superiority of Dotarem®-enhanced MRI as compared to unenhanced MRI in CNS (intracranial and spine) lesions in terms of lesion visualization (lesion border delineation, visualization of internal morphology and degree of contrast enhancement).Blinded reading performed by three independent off-site readers (neuroradiologists) will be used to assess the study primary criteria. The study will be considered successful if two of the three readers simultaneously meet co-primary objectives.


Critère d'inclusion

  • Patient with Central Nervous System (CNS) Lesions