Abstract | BACKGROUND AND PURPOSE: MATERIALS AND METHODS: We performed crossover, intraindividual comparison of 0.1-mmol/kg gadobenate with 0.1-mmol/kg gadoterate (Arm 1) and 0.05-mmol/kg gadobenate with 0.1-mmol/kg gadoterate (Arm 2). Adult patients with suspected or known brain tumors were randomized to Arm 1 (70 patients) or Arm 2 (107 patients) and underwent 2 identical examinations at 1.5 T. The agents were injected in randomized-sequence order, and the 2 examinations were separated by 2-14 days. MR imaging scanners, imaging sequences (T1-weighted spin-echo and T1-weighted high-resolution gradient-echo), and acquisition timing were identical for the 2 examinations. Three blinded readers evaluated images for diagnostic information (degree of definition of lesion extent, lesion border delineation, visualization of lesion internal morphology, contrast enhancement) and quantitatively for percentage lesion enhancement and lesion-to-background ratio. Safety assessments were performed. RESULTS: In Arm 1, a highly significant superiority (P < .002) of 0.1-mmol/kg gadobenate was demonstrated by all readers for all end points. In Arm 2, no significant differences (P > .1) were observed for any reader and any end point, with the exception of percentage enhancement for reader 2 (P < .05) in favor of 0.05-mmol/kg gadobenate. Study agent-related adverse events were reported by 2/169 (1.2%) patients after gadobenate and by 5/175 (2.9%) patients after gadoterate. CONCLUSIONS: Significantly superior morphologic information and contrast enhancement are demonstrated on brain MR imaging with 0.1-mmol/kg gadobenate compared with 0.1-mmol/kg gadoterate. No meaningful differences were recorded between 0.05-mmol/kg gadobenate and 0.1-mmol/kg gadoterate.
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Authors | M Vaneckova, M Herman, M P Smith, M Mechl, K R Maravilla, J Weichet, M V Spampinato, J Žižka, F J Wippold 2nd, J J Baima, R Babbel, E Bültmann, R Y Huang, J-H Buhk, A Bonafé, C Colosimo, S Lui, M A Kirchin, N Shen, G Pirovano, A Spinazzi |
Journal | AJNR. American journal of neuroradiology
(AJNR Am J Neuroradiol)
Vol. 36
Issue 9
Pg. 1589-98
(Sep 2015)
ISSN: 1936-959X [Electronic] United States |
PMID | 26185325
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | © 2015 by American Journal of Neuroradiology. |
Chemical References |
- Contrast Media
- Organometallic Compounds
- gadobenic acid
- Meglumine
- gadoterate meglumine
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Topics |
- Adult
- Aged
- Brain Neoplasms
(pathology)
- Contrast Media
- Cross-Over Studies
- Female
- Humans
- Magnetic Resonance Imaging
(methods)
- Male
- Meglumine
(analogs & derivatives)
- Middle Aged
- Organometallic Compounds
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