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

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 of 27 sites; the diagnosis was confirmed with one of nine imaging or surgical procedures within 8 weeks before or after MR imaging. After injection, no clinically significant changes were noted in laboratory values, physical examination, or vital signs. Adverse clinical events possibly or probably associated with injection of gadoteridol were seen in 18 of 411 patients (4.4%); the most common were dysgeusia and mild nausea, and all abated without residual effects. MR images enhanced with gadoteridol in patients with confirmed disease provided more diagnostic information than unenhanced images in 128 of 175 brain examinations (73.1%) and 93 of 137 spinal examinations (67.9%). A change in diagnosis because of additional information from contrast-enhanced images was considered likely in 63 of 214 cranial and 54 of 161 spinal studies.