MnDPDP for MR imaging of the liver. Results of an independent image evaluation of the European phase III studies

Abstract

Purpose: To evaluate the diagnostic efficacy of mangafodipir trisodium (MnDPDP, Teslascan) as a new contrast agent for MR imaging of the liver based on an independent evaluation of the MR images from the European phase III studies.

Material and methods: MR imaging of the liver was done at 0.5-2.0 T in 17 European centres and included T1-weighted spin-echo and gradient-echo sequences before and after administration of MnDPDP to patients at a dose of 5 mumol/kg b.w. T2-weighted images were 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 experienced radiologists who were not involved in the on-site clinical trials.

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 post-contrast images were found to be statistically significantly superior to the pre-contrast images in confidence in the presence of a lesion (p < or = 0.0001), quality of lesion delineation (p < or = 0.0001), lesion conspicuity (p < or = 0.0001) and in the confidence in the diagnosis of a lesion (p = 0.001).

Conclusion: This independent evaluation of the European phase III trials confirmed the superiority of MnDPDP-enhanced MR images over unenhanced images for lesion detection and characterization.