Cesare Colosimo MD, Presenter: Research Consultant, Bayer AG Research Consultant, Bracco Group

Emilio Cianciulli, Abstract Co-Author: Nothing to Disclose

Claudio Fonda MD, Abstract Co-Author: Grant, Bracco Group

Mieczyslaw Pasowicz MD, Abstract Co-Author: Nothing to Disclose

Philippe Demaerel MD, PhD, Abstract Co-Author: Nothing to Disclose

Peiyi Gao MD, PhD, Abstract Co-Author: Researcher, Bracco Group

Paolo Tortori-Donati MD, Abstract Co-Author: Nothing to Disclose

John R. Parker, Abstract Co-Author: Employee, Bracco Group

et al, Abstract Co-Author: Nothing to Disclose

To summarize the safety, pharmacokinetics, and efficacy of the higher-relaxivity MR contrast agent gadobenate dimeglumine (Gd-BOPTA; MultiHance®) in children.

Safety was evaluated in 151 subjects receiving Gd-BOPTA at a dose of 0.1 mmol/kg bodyweight. Of these subjects, 85 participated in a comparison study in which 89 subjects received an equal dose of gadopentetate dimeglumine (Gd-DTPA; Magnevist®). Pharmacokinetics (PK) of Gd-BOPTA was determined in 25 children using serial 24-hour blood and urine collections. Image quality was evaluated in 70 patients receiving 0.1 mmol/kg Gd-BOPTA, including 29 children that were evaluated in comparison to 34 children who received an equal dose of Gd-DTPA.

Of the 151 patients evaluated for safety, 18 (11.6%) patients experienced adverse events (AEs), most of which were mild. The most commonly reported AEs were fever and headache. Modest increases and decreases in vital signs were recorded, but no significant changes in laboratory parameters or ECGs were observed. AE rates were similar (p=0.75) after Gd-BOPTA (11 subjects, 13%) and Gd-DTPA (13 subjects, 14%). The PK data best fit a 2-compartment model, with more than 90% recovery in urine at 24 hours. In children with enhancing lesions, contrast enhancement with Gd-BOPTA was considered good-to-excellent in all subjects, resulting in improved definition of disease extent, lesion border delineation, and visualization of lesion internal morphology. Pre- to postdose changes in lesion visualization were significantly greater for Gd-BOPTA than Gd-DTPA at both the lesion (p=0.011) and patient (p=0.008) level.

Gd-BOPTA is well tolerated, with safety and pharmacokinetics comparable to other gadolinium contrast agents. Gd-BOPTA provided excellent enhancement of brain or spine lesions in children with enhancing lesions. Due to its higher relaxivity, Gd-BOPTA potentially improves lesion characterization (eg, definition of tumor borders and extent of disease, visualization of vascular malformations, evaluation of the relationship between adjacent neurovascular structures and the neoplasm itself) as well as potentially augmenting detection of small or poorly-enhancing tumors.

Our study results suggest that, as in adults, Gd-BOPTA is safe and efficacious for contrast-enhanced MRI of CNS lesions in children.

Colosimo, C, Cianciulli, E, Fonda, C, Pasowicz, M, Demaerel, P, Gao, P, Tortori-Donati, P, Parker, J, et al, , Gadobenate Dimeglumine for Contrast-enhanced MRI of the Central Nervous System in Children.  Radiological Society of North America 2008 Scientific Assembly and Annual Meeting, February 18 - February 20, 2008 ,Chicago IL. http://archive.rsna.org/2008/6020011.html