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.
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.
Padovani
B
B
Département de Radiologie, Hôpital Pasteur, Nice, France.
Lecesne
R
R
Raffaelli
C
C
Chevallier
P
P
Drouillard
J
J
Bruneton
J N
JN
Lambrechts
M
M
Gordon
P
P
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
D003287:Contrast Media; D008345:Manganese; D011732:Pyridoxal Phosphate; D004492:Edetic Acid; C060076:N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid