Clinical results with Resovist: a phase 2 clinical trial.

Abstract

PURPOSE: To investigate the superparamagnetic iron oxide (Resovist) designed for contrast material-enhanced magnetic resonance imaging of the liver. MATERIALS AND METHODS: A phase 2 trial was performed in 33 patients with no more than five known focal solid liver lesions. Resovist was administered intravenously at doses of 4, 8, and 16 mumol of iron per kilogram of body weight. Postcontrast 1.0-T imaging was started 30 minutes after injection. RESULTS: Resovist significantly (P < or = .05) decreased liver signal intensity and increased lesion-to-liver contrast-to-noise ratio (C/N) and the number of detectable liver lesions: fast spin-echo (SE) (echo time, 90 msec) precontrast C/N, 11.7 +/- 7.9 [standard deviation]; postcontrast [8-mumol Fe/Kg] C/N, 29.2 +/- 14.2). The dose of 8 mumol Fe/kg was sufficient for the detection of focal liver lesions, and T2-weighted fast SE with an echo time of 90 msec was the overall best pulse sequence. CONCLUSION: Resovist is a safe contrast agent, and a dose of 8 mumol Fe/kg is sufficient to enhance detection of focal liver lesions at T2-weighted fast SE MR imaging.