TY - JOUR
T1 - Cerebral neoplastic enhancing lesions
T2 - Multicenter, randomized, crossover intraindividual comparison between gadobutrol (1.0 M) and gadoterate meglumine (0.5 M) at 0.1 mmol Gd/kg body weight in a clinical setting
AU - Anzalone, Nicoletta
AU - Scarabino, Tommaso
AU - Venturi, Carlo
AU - Cristaudo, Concetto
AU - Tartaro, Armando
AU - Scotti, Giuseppe
AU - Zimatore, Domenico
AU - Floris, Roberto
AU - Carriero, Alessandro
AU - Longo, Marcello
AU - Cirillo, Mario
AU - Cova, Maria Assunta
AU - Gatti, Simona
AU - Voth, Matthias
AU - Colosimo, Cesare
N1 - Funding Information:
In this study, for the visualization of enhancing brain lesions gadobutrol was statistically superior compared to gadoterate meglumine when using equal Gd doses. Following standardized data acquisition under routine conditions in twelve different study centers the overall preference for gadobutrol was higher compared to gadoterate meglumine as shown in an off-site blinded reading. This was also supported by the assessments of the (blinded) on-site investigators.
PY - 2013/1
Y1 - 2013/1
N2 - Objective: Two macrocyclic extracellular contrast agents, one-molar neutral gadobutrol and ionic gadoterate meglumine, were compared to determine the overall preference for one or the other in a clinical setting. Materials and methods: Multicenter, randomized, single-blind, intra-individually controlled, comparison study with a corresponding blinded read. Efficacy analysis was based on 136 patients who underwent identical MRI examinations: group A first received 1.0 M gadobutrol followed by 0.5 M gadoterate meglumine 48 h to 7 days later; group B had a reversed administration order. Three independent blinded readers assessed off-site their overall diagnostic preference (primary efficacy parameter) based on a matched pairs approach. Results: Superiority of gadobutrol over gadoterate meglumine was demonstrated for the qualitative assessment of overall preference across all readers by a statistically significant difference between both contrast agents for this primary endpoint. Preferences in lesion enhancement (secondary endpoint) were also found significantly in favor of gadobutrol. For preference in lesion delineation from surrounding tissue/edema and for internal structure only a trend towards a higher proportion for gadobutrol was found (except for internal structure reported by one reader, which showed a result of statistical significance). Lesion contrast and relative lesion enhancement (quantitative parameters) were statistically significantly higher for gadobutrol compared to gadoterate meglumine. Conclusion: Contrast-enhanced MRI of neoplastic brain lesions at a dose of 0.1 mmol Gd/kg body weight, assessed in a standardized off-site blinded reading, results in a significantly higher qualitative and quantitative preference for gadobutrol compared to gadoterate meglumine.
AB - Objective: Two macrocyclic extracellular contrast agents, one-molar neutral gadobutrol and ionic gadoterate meglumine, were compared to determine the overall preference for one or the other in a clinical setting. Materials and methods: Multicenter, randomized, single-blind, intra-individually controlled, comparison study with a corresponding blinded read. Efficacy analysis was based on 136 patients who underwent identical MRI examinations: group A first received 1.0 M gadobutrol followed by 0.5 M gadoterate meglumine 48 h to 7 days later; group B had a reversed administration order. Three independent blinded readers assessed off-site their overall diagnostic preference (primary efficacy parameter) based on a matched pairs approach. Results: Superiority of gadobutrol over gadoterate meglumine was demonstrated for the qualitative assessment of overall preference across all readers by a statistically significant difference between both contrast agents for this primary endpoint. Preferences in lesion enhancement (secondary endpoint) were also found significantly in favor of gadobutrol. For preference in lesion delineation from surrounding tissue/edema and for internal structure only a trend towards a higher proportion for gadobutrol was found (except for internal structure reported by one reader, which showed a result of statistical significance). Lesion contrast and relative lesion enhancement (quantitative parameters) were statistically significantly higher for gadobutrol compared to gadoterate meglumine. Conclusion: Contrast-enhanced MRI of neoplastic brain lesions at a dose of 0.1 mmol Gd/kg body weight, assessed in a standardized off-site blinded reading, results in a significantly higher qualitative and quantitative preference for gadobutrol compared to gadoterate meglumine.
KW - Blinded reading
KW - Clinical trial
KW - Diagnostic study
KW - Gadolinium-based contrast agents (GBCA)
KW - MRI
UR - http://www.scopus.com/inward/record.url?scp=84871834825&partnerID=8YFLogxK
U2 - 10.1016/j.ejrad.2011.07.005
DO - 10.1016/j.ejrad.2011.07.005
M3 - Article
SN - 0720-048X
VL - 82
SP - 139
EP - 145
JO - European Journal of Radiology
JF - European Journal of Radiology
IS - 1
ER -