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A multicenter, randomized, double-blind, crossover, phase 3 study to determine the safety and efficacy of gadobutrol 1.0 molar (Gadovist®) in patients referred for contrast-enhanced MRI of the central...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-004746-33

A multicenter, randomized, double-blind, crossover, phase 3 study to determine the safety and efficacy of gadobutrol 1.0 molar (Gadovist®) in patients referred for contrast-enhanced MRI of the central nervous system (CNS)

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Extrait

Superiority of combined unenhanced and gadobutrol-enhanced magnetic resonance imaging (MRI) compared to unenhanced MRI based on the evaluation of the following: • Degree of contrast enhancement • Assessment of border delineation • Internal morphology of lesions And noninferiority of combined unenhanced and gadobutrol-enhanced magnetic resonance imaging (MRI) compared to unenhanced MRI based on the evaluation of the following: • Total number of lesions detected

Critère d'inclusion

  • Male and female patients of any ethnic group who are referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms or results of a previous imaging procedure

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