MNDPDP FOR MR-IMAGING OF THE LIVER - RESULTS OF AN INDEPENDENT IMAGE EVALUATION OF THE EUROPEAN PHASE-III STUDIES

Purpose: To evaluate the diagnostic efficacy of mangafodipir trisodium (MnDPDP, Teslascan) as a new contrast agent for MR imaging of the liv er based on an independent evaluation of the MR images from the Europe an phase III studies. Material and Methods: MR imaging of the liver wa s done at 0.5-2.0 T in 17 European centres and included T1-weighted sp in-echo and gradient-echo sequences before and after administration of MnDPDP to patients at a dose of 5 mu mol/kg b.w. T2-weighted images w ere also obtained in all cases before the i.v. injection of the agent. Images of a total of 592 patients were evaluated by 4 independent exp erienced radiologists who were not involved in the on-site clinical tr ials. Results: Statistically significantly more lesions were detected (p=0.0014) in MnDPDP-enhanced T1-weighted MR images than in unenhanced images. T1-weighted gradient-echo sequences were found to be superior to T1-weighted spin-echo sequences after injection of MnDPDP. The pos t-contrast images were found to be statistically significantly superio r to the pre-contrast images in confidence in the presence of a lesion (p less than or equal to 0.0001), quality of lesion delineation (p le ss than or equal to 0.0001), lesion conspicuity (p less than or equal to 0.0001) and in the confidence in the diagnosis of a lesion (p=0.001 ). Conclusion: This independent evaluation of the European phase In tr ials confirmed the superiority of MnDPDP-enhanced MR images over unenh anced images for lesion detection and characterization.