Diagnostic efficacy and safety of MRI of the liver with superparamagnetic iron oxide particles (SH U 555 A)

The purpose of this study was to evaluate the diagnostic efficacy and safety of an intravenous injection of magnetic resonance imaging (MRI) contrast agent, SH U 555 A, in adult patients with known focal liver lesions. Pre- and post-contrast image sets were obtained in 19 patients after injection of SH U 555 A as a part of a phase III clinical trial (patients <60 kg body weight received 0.9 mL and patients >60 kg received 1.4 mL). Three blinded readers evaluated the post-contrast images. Blood pressure and heart rate were recorded and laboratory tests were performed at baseline, during and immediately after the procedure, and four and 24 hours after the MR procedure. On post-contrast MRI, there was statistically significant improvement in diagnostic confidence, visualization, delineation, and contrast between the lesions and the healthy parenchyma in comparison to precontrast. Twenty more lesions were detected on post-contrast images. The management in six patients (31.7%) was changed after post-contrast imaging. Changes in vital signs and laboratory tests were minimal and did not affect the patients' clinical condition. Only a moderate allergic reaction (diffuse erythematous rash) was recorded. SH U 555 A is an effective and safe contrast agent for MRI of the liver. (C) 2001 Wiley-Liss, Inc.