Phase III multicenter clinical investigation to determine the safety and efficacy of gadoteridol in children suspected of having neurologic disease.

A phase III open-label clinical trial was conducted at 11 institutions to determine the safety and efficacy of gadoteridol in children suspected of having neurologic disease. One hundred three children were included in the safety analysis; 92 were evaluated for efficacy (76 intracranial and 16 spinal examinations). Three adverse events were reported in two children. All adverse events were considered minor and resolved spontaneously without treatment or sequelae. In a comparison of enhanced T1-weighted magnetic resonance images with unenhanced T1- and T2-weighted images, enhancement of disease was noted in 70% of the intracranial and 38% of the spinal examinations. Additional diagnostic information was reported in 82% of the postcontrast intracranial examinations and 62% of the spinal examinations. Use of this additional information contributed to a potential modification of patient diagnosis in 48% of intracranial and 20% of spinal cases with additional information. These results indicate excellent safety and efficacy for use of gadoteridol in children with suspected intracranial or spinal disease.