Efficacy, and safety of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: Results of the US multicenter phase III clinical trials.Efficacy of early imaging

The efficacy of contrast-enhanced magnetic resonance imaging (MRI) for dete cting and characterizing, or excluding, hepatic masses was assessed in 404 patients, following the intravenous administration of mangafodipir trisodiu m. (MnDPDP) injection, a hepatic MRI contrast agent. An initial contrast-en hanced computed tomography (CT) examination was followed by unenhanced MRI, injection of MnDPDP (5 mu mol/kg IV] and enhanced MRI at 15 minutes post i njection. Agreement of the radiologic diagnoses with the patients' final di agnoses was higher for enhanced MRI and for the combined unenhanced and enh anced MRI evaluations than for unenhanced MRI alone or enhanced CT using th e clinical diagnosis as the gold standard. Mangafodipir-enhanced MRI unique ly provided additional diagnostic information in 48% of the patients, and p atient management. was consequently altered in 6% of the patients. MnDPDP-e nhanced MRI was comparable or superior to unenhanced MRI and enhanced CT fo r the detection, classification, and diagnosis of focal liver lesions in pa tients with known or suspected focal liver disease. (C) 2000 Wiley-Liss, In c.