title: Cerebral neoplastic enhancing lesions: multicenter, randomized, crossover intraindividual comparison between gadobutrol (1.0M) and gadoterate meglumine (0.5M) at 0.1 mmol Gd/kg body weight in a clinical setting.
abstract: 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.
  
  
  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 1.0M gadobutrol followed by 0.5M 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.
  
  
  CONCLUSIONS
  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.
authors: Department of Neuroradiology, Scientific Institute H.S. Raffaele, Via Olgettina 60, 20132 Milan, Italy. anzalone.nicoletta@hsr.it
authors: Nicoletta
authors: N
authors: Anzalone
authors: Tommaso
authors: T
authors: Scarabino
authors: Carlo
authors: C
authors: Venturi
authors: Concetto
authors: C
authors: Cristaudo
authors: Armando
authors: A
authors: Tartaro
authors: Giuseppe
authors: G
authors: Scotti
authors: Domenico
authors: D
authors: Zimatore
authors: Roberto
authors: R
authors: Floris
authors: Alessandro
authors: A
authors: Carriero
authors: Marcello
authors: M
authors: Longo
authors: Mario
authors: M
authors: Cirillo
authors: Maria Assunta
authors: MA
authors: Cova
authors: Simona
authors: S
authors: Gatti
authors: Matthias
authors: M
authors: Voth
authors: Cesare
authors: C
authors: Colosimo
mesh_terms: D001921:Brain / Q000473:pathology*; D001932:Brain Neoplasms / Q000473:pathology*; D003287:Contrast Media / Q000008:administration & dosage; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008536:Meglumine / Q000008:administration & dosage; D008875:Middle Aged; D015588:Observer Variation; D009942:Organometallic Compounds / Q000008:administration & dosage; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016037:Single-Blind Method
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol; D008536:Meglumine; C072417:gadoterate meglumine