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


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).


CONCLUSIONS
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.
Rummeny
E J
EJ
Department of Clinical Radiology, University of Münster, Germany. rummeny@uni-muenster.de
Torres
C G
CG
Kurdziel
J C
JC
Nilsen
G
G
Op de Beeck
B
B
Lundby
B
B
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000008:administration & dosage; D004492:Edetic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005060:Europe; D005260:Female; D006801:Humans; D008099:Liver / Q000473:pathology*; D008113:Liver Neoplasms / Q000175:diagnosis / Q000556:secondary; D008279:Magnetic Resonance Imaging / Q000379:methods* / Q000706:statistics & numerical data; D008297:Male; D008345:Manganese / Q000008:administration & dosage; D008875:Middle Aged; D011732:Pyridoxal Phosphate / Q000008:administration & dosage / Q000031:analogs & derivatives*
D003287:Contrast Media; D008345:Manganese; D011732:Pyridoxal Phosphate; D004492:Edetic Acid; C060076:N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid