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

Abstract

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.

Currently used non-specific extracellular MR contrast media

“…No significant adverse clinical events or clinically important trends in vital signs have been reported in association with the use of Gd chelates in this patient group [33]. In addition, the use of gadopentetate dimeglumine is approved in Europe at doses up to 0.2 mmol/kg for CNS studies and body MRI in infants (day 1 of life).…”

MR contrast agents: Physical and pharmacologic basics

“…In conclusion, while many studies have confirmed the "added value" of contrast-enhanced images for pediatric MRI (97)(98)(99)(100)(101)(102)(103)(104)(105)(106)(107)(108), the question is whether or not routine contrast administration in children is warranted. Given that there appears to be an identical safety profile in the pediatric and adult populations, it seems reasonable to administer Gd-based agents to children in the same basic situations considered for adults, particularly in the evaluation of neoplastic or inflammatory disease.…”

Pharmacokinetics of gadoversetamide injection, a gadolinium-based contrast agent, in pediatric patients

“…The administration of exogenous MR contrast agents has been shown to improve contrast enhancement and the ability to distinguish pathologic tissue from normal tissue [1]. In addition to adult applications, MR contrast agents have also demonstrated clinical diagnostic utility in pediatric patients [2][3][4].…”