To evaluate the diagnostic efficacy (accuracy, sensitivity, specificity) of 1.0 M gadobutrol
versus 0.5 M gadopentetate
for the classification of lesions as either benign or malignant in patients with known or suspected liver lesions
Methods and Materials:
A multicenter, phase-III, randomized, interindividually controlled comparison study with blinded reader evaluation was performed to investigate the diagnostic efficacy of a bolus injection of 1.0 M gadobutrol
compared with 0.5 M gadopentetate
at a dose of 0.1 mmol Gd/kg BW. The imaging protocol included a dynamic 3D-evaluation, static conventional, and fat saturated T1-weighted sequences. MR datasets were evaluated by 3 independent radiologists. The standard of reference was defined by an independent truth panel (radiologist or hepatologist). The safety evaluation included adverse events, vital signs, and physical examination.
A total of 497 of 572 patients were eligible for the final efficacy analysis. Noninferiority of gadobutrol
-enhanced magnetic resonance imaging (MRI
) for the classification of liver lesions
was demonstrated on the basis of diagnostic accuracy determined by the on-site investigators (−0.098, 0.021) as well as for the average reader of the blinded evaluation (−0.096, 0.014) (95% confidence interval), compared with the predefined standard of reference. Very similar increases in sensitivity (ranging from ∼10% to ∼55%) and specificity (ranging from ∼1%–∼18%) compared with precontrast MRI
were also observed for the 2 contrast agent groups, with maximum differences of 4%.
Very similar, low rates of adverse events were recorded for each of the 2 groups. No clinically relevant changes in vital signs or the results of the physical examination were observed in any patient.
This study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol
(0.1 mmol/kg body weight) to 0.5 M gadopentetate
(0.1 mmol/kg body weight) in the diagnostic assessment of liver lesions
with contrast-enhanced MRI
. The known excellent safety profile of gadobutrol
was confirmed in this clinical trial and is similar to that of gadopentetate