Clinical safety and efficacy of gadoteridol: a study in 411 patients with suspected intracranial and spinal disease.

摘要: In this phase III study, 411 adult patients with suspected intracranial or spinal disease underwent magnetic resonance (MR) imaging before and after intravenous injection of 0.1 mmol/kg gadoteridol (gadolinium 1,4,7-tris [carboxymethyl]-10-[2'-hydroxypropyl]-1,4,7,10-tetraazacyclododecane+ ++). MR images were evaluated by a single unblinded reader at each 27 sites; the diagnosis was confirmed one nine surgical procedures within 8 weeks imaging. After injection, no clinically significant changes noted in laboratory values, physical examination, vital signs. Adverse clinical events possibly probably associated seen 18 (4.4%); most common dysgeusia mild nausea, all abated without residual effects. enhanced provided more diagnostic information than unenhanced 128 175 brain examinations (73.1%) 93 137 ...