title: A multicenter, randomized, controlled, single-blind comparison phase III study to determine the efficacy and safety of gadobutrol 1.0 M versus gadopentetate dimeglumine following single injection in patients referred for contrast-enhanced MRI of the body regions or extremities.
abstract: OBJECTIVE
  To demonstrate the noninferiority of gadobutrol-enhanced magnetic resonance imaging (MRI) compared with gadopentetate dimeglumine-enhanced MRI in Asian patients referred for contrast-enhanced imaging of the body or extremities.
  
  
  METHODS
  A multicenter, parallel-group comparison study of Asian adults referred for contrast-enhanced MRI were randomized (1:1) to either gadobutrol or gadopentetate dimeglumine. Lesions were assessed for three primary visualization variables: degree of contrast enhancement, border delineation, and internal morphology. Secondary efficacy variables included number of lesions detected, match of MRI diagnosis with final clinical diagnosis, and sensitivity and specificity for malignant lesion detection. Safety was monitored for 24 ± 4 hours after contrast agent administration.
  
  
  RESULTS
  A total of 363 patients received either gadobutrol (n = 168) or gadopentetate dimeglumine (n = 178). Mean total scores for three primary visualization variables were 9.39 and 9.34 for gadobutrol and gadopentetate dimeglumine, respectively. The proportion of patients with matched MRI and final diagnosis and sensitivity for malignant lesion detection was greater for unenhanced versus combined images (gadobutrol: 72.2% vs. 81.7%; gadopentetate dimeglumine: 76.2% vs. 82.2%, respectively). Both contrast agents were well tolerated.
  
  
  CONCLUSIONS
  Gadobutrol (0.1 mmol/kg BW) was well tolerated and effective in Asian patients referred for contrast-enhanced MRI of the body or extremities.
authors.affiliation: Department of Radiology, Juntendo University, Faculty of Medicine, Tokyo, Japan.
authors.forename: Ryohei
authors.initials: R
authors.lastname: Kuwatsuru
authors.forename: Satoru
authors.initials: S
authors.lastname: Takahashi
authors.forename: Shigeaki
authors.initials: S
authors.lastname: Umeoka
authors.forename: Ryo
authors.initials: R
authors.lastname: Sugihara
authors.forename: Mengsu
authors.initials: M
authors.lastname: Zeng
authors.forename: Yi
authors.initials: Y
authors.lastname: Huan
authors.forename: Weijun
authors.initials: W
authors.lastname: Peng
authors.forename: Lin
authors.initials: L
authors.lastname: Ma
authors.forename: Liang
authors.initials: L
authors.lastname: Guo
authors.forename: Gaojun
authors.initials: G
authors.lastname: Teng
authors.forename: Weiwu
authors.initials: W
authors.lastname: Yao
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Tozaki
authors.forename: Masahiro
authors.initials: M
authors.lastname: Endo
authors.forename: Shuichiro
authors.initials: S
authors.lastname: Kaji
authors.forename: Tokugen
authors.initials: T
authors.lastname: Ro
authors.forename: Seong
authors.initials: S
authors.lastname: Tae Hahn
authors.forename: Byung
authors.initials: B
authors.lastname: Chul Kang
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nishimura
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Sugawara
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.forename: Josy
authors.initials: J
authors.lastname: Breuer
authors.forename: Yasuko
authors.initials: Y
authors.lastname: Aitoku
mesh_terms: D002681:China; D003287:Contrast Media / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D019786:Gadolinium DTPA / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007267:Injections; D007564:Japan; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D056910:Republic of Korea; D012680:Sensitivity and Specificity; D016037:Single-Blind Method
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol; D019786:Gadolinium DTPA
keywords: contrast agents; gadobutrol; gadopentetate dimeglumine; magnetic resonance imaging