• Ryohei Kuwatsuru, Satoru Takahashi, Shigeaki Umeoka, Ryo Sugihara, Mengsu Zeng, Yi Huan, Weijun Peng, Lin Ma, Liang Guo, Gaojun Teng, Weiwu Yao, Mitsuhiro Tozaki, Masahiro Endo, Shuichiro Kaji, Tokugen Ro, Seong Tae Hahn, Chul KangByungB, Hiroshi Nishimura, Yoshifumi Sugawara, Nobuyuki Katakami, Josy Breuer, and Yasuko Aitoku.
• Department of Radiology, Juntendo University, Faculty of Medicine, Tokyo, Japan.
• J Magn Reson Imaging. 2015 Feb 1; 41 (2): 404-13.

PurposeTo 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.Materials And MethodsA 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.ResultsA 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.ConclusionGadobutrol (0.1 mmol/kg BW) was well tolerated and effective in Asian patients referred for contrast-enhanced MRI of the body or extremities.© 2014 Wiley Periodicals, Inc.

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