title: Tolerability and utility of mangafodipir trisodium injection (MnDPDP) at the dose of 5 mumol/kg body weight in detecting focal liver tumors: results of a phase III trial using an infusion technique.
abstract: OBJECTIVE
  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).
  
  
  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 mumol/kg MnDPDP, at a concentration of 10 mumol/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%).
  
  
  CONCLUSIONS
  MnDPDP is a well-tolerated contrast agent allowing better MR detection of focal hepatic lesions than non-enhanced MR or contrast-enhanced CT.
authors.affiliation: Département de Radiologie, Hôpital Pasteur, Nice, France.
authors.forename: B
authors.initials: B
authors.lastname: Padovani
authors.forename: R
authors.initials: R
authors.lastname: Lecesne
authors.forename: C
authors.initials: C
authors.lastname: Raffaelli
authors.forename: P
authors.initials: P
authors.lastname: Chevallier
authors.forename: J
authors.initials: J
authors.lastname: Drouillard
authors.forename: J N
authors.initials: JN
authors.lastname: Bruneton
authors.forename: M
authors.initials: M
authors.lastname: Lambrechts
authors.forename: P
authors.initials: P
authors.lastname: Gordon
mesh_terms: D006528:Carcinoma, Hepatocellular / Q000175:diagnosis*; D003287:Contrast Media / Q000008:administration & dosage* / Q000009:adverse effects; D004492:Edetic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008113:Liver Neoplasms / Q000175:diagnosis* / Q000556:secondary; D008297:Male; D008345:Manganese / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D011732:Pyridoxal Phosphate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D014057:Tomography, X-Ray Computed
chemical_list: D003287:Contrast Media; D008345:Manganese; D011732:Pyridoxal Phosphate; D004492:Edetic Acid; C060076:N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid