PURPOSE: To assess the potential advantages of using a 1.0 mol/L versus 0.5 mol/L gadobutrol formulation for magnetic resonance (MR) brain perfusion imaging. MATERIALS AND METHODS:Forty-three healthy volunteers were enrolled in an intraindividually controlled, randomized crossover comparison study. Two gadobutrol formulations-0.5 and 1.0 mol/L- were randomly injected during two separate treatment periods. For intraindividual comparison of effectiveness parameters, single-section gradient-echo brain perfusion MR imaging was performed under identical conditions for both investigations. Quantitative and qualitative evaluations were performed. Differences between the two gadobutrol formulations were evaluated at analysis of covariance and tested for statistical significance (P <.05) with a t test. RESULTS: Use of 1.0 mol/L gadobutrol resulted in a significantly smaller bolus width at half maximum signal intensity decrease, a smaller mean peak time, a higher contrast and contrast-to-noise ratio between gray and white matter, and significant increases in both maximum change in transverse relaxation rate (DeltaR2max) and differences in peak enhancement in gray matter among all volunteers (P <.001). In white matter, increases in DeltaR2max (P =.262) and in differences in peak enhancement (P =.262) were smaller and not significant (P =.292). Parameter map analysis revealed improved quality and superior contrast in relative regional cerebral blood flow (P =.034) and mean transit time (P <.001). The lack of difference regarding relative regional cerebral blood volume maps was consistent with the use of the same dose of each gadobutrol formulation. CONCLUSION: Brain perfusion images obtained with 1.0 mol/L gadobutrol were superior to those obtained with 0.5 mol/L gadobutrol in healthy volunteers examined with the described MR imaging protocol.
RCT Entities:
PURPOSE: To assess the potential advantages of using a 1.0 mol/L versus 0.5 mol/L gadobutrol formulation for magnetic resonance (MR) brain perfusion imaging. MATERIALS AND METHODS: Forty-three healthy volunteers were enrolled in an intraindividually controlled, randomized crossover comparison study. Two gadobutrol formulations-0.5 and 1.0 mol/L- were randomly injected during two separate treatment periods. For intraindividual comparison of effectiveness parameters, single-section gradient-echo brain perfusion MR imaging was performed under identical conditions for both investigations. Quantitative and qualitative evaluations were performed. Differences between the two gadobutrol formulations were evaluated at analysis of covariance and tested for statistical significance (P <.05) with a t test. RESULTS: Use of 1.0 mol/L gadobutrol resulted in a significantly smaller bolus width at half maximum signal intensity decrease, a smaller mean peak time, a higher contrast and contrast-to-noise ratio between gray and white matter, and significant increases in both maximum change in transverse relaxation rate (DeltaR2max) and differences in peak enhancement in gray matter among all volunteers (P <.001). In white matter, increases in DeltaR2max (P =.262) and in differences in peak enhancement (P =.262) were smaller and not significant (P =.292). Parameter map analysis revealed improved quality and superior contrast in relative regional cerebral blood flow (P =.034) and mean transit time (P <.001). The lack of difference regarding relative regional cerebral blood volume maps was consistent with the use of the same dose of each gadobutrol formulation. CONCLUSION: Brain perfusion images obtained with 1.0 mol/L gadobutrol were superior to those obtained with 0.5 mol/L gadobutrol in healthy volunteers examined with the described MR imaging protocol.
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