Tolerability and utility of mangafodipir trisodium injection (MnDPDP) at the dose of 5 μmol/kg body weight in detecting focal liver tumors: results of a phase III trial using an infusion technique

Abstract

Purpose: To evaluate the tolerability of mangafodipir trisodium (MnDPDP) and its utility for enhancing the ability of magnetic resonance (MR) imaging to detect focal hepatic lesions compared with non-enhanced MR and contrast-enhanced computed tomography (CT). Materials and methods: 119 patients with focal hepatic lesions were examined by MR and by contrast-enhanced CT. MR was performed before and after the infusion of 5 μmol/kg MnDPDP, at a concentration of 10 μmol/ml. Histologic confirmation was obtained in 79 patients. Results: There were no severe adverse events. Five patients reported mild adverse events related to the infusion. MnDPDP-enhanced SE T1 and GE T1 sequences revealed more focal lesions than the same sequences before contrast infusion in, respectively 22.6 and 36.1% of the cases, and fewer focal lesions in, respectively 5.9 and 1.7% of the cases. Contrast-enhanced MR demonstrated more focal lesions than the SE T2 sequence in 29.4% of cases and fewer lesions in 5.9% of cases. MnDPDP-enhanced MR revealed more nodules than CT in 31.1% of cases and fewer nodules in 13.4% of cases. The additional information provided by MnDPDP enhancement led to modification of management for 12 patients (10.1%). Conclusion: MnDPDP is a well-tolerated contrast agent allowing better MR detection of focal hepatic lesions than non-enhanced MR or contrast-enhanced CT.