Superparamagnetic iron oxide particles (SH U 555 A): evaluation of efficacy in three doses for hepatic MR imaging.
(Clinical Trial;Journal Article;Multicenter Study)
PURPOSE: To evaluate the efficacy of SH U 555 A in three doses for magnetic resonance (MR) imaging in the liver and to establish the best postinjection time point for liver MR imaging. MATERIALS AND METHODS: Pre- and postcontrast image sets obtained in 169 patients after injection of SH U 555 A (randomly, 4, 8, or 16 mumol of iron per kilogram of body weight). Three blinded readers evaluated the precontrast and 10- and 40-minute postcontrast MR images of 54, 58, and 57 patients, respectively. RESULTS: Statistically significant differences were observed in diagnostic confidence between images obtained with a dose of 4 or 16 mumol Fe/kg (P = .011) and in good or excellent improvement, respectively, in delineation of lesions on 10-minute postcontrast images (P = .001). No apparent differences in the efficacy evaluation were seen between the 10- and 40-minute postcontrast imaging time points. CONCLUSION: There was a dose-dependent postcontrast improvement in evaluated efficacy parameters (diagnostic confidence, visual evaluations) after injection of SH U 555 A. Accumulation phase imaging could begin as early as 10 minutes after administration.
Shamsi, K; Balzer, T; Saini, S; Ros, PR; Nelson, RC; Carter, EC; Tollerfield, S; Niendorf, HP
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