Diagnostic efficacy of MnDPDP in MR imaging of the liver. A phase III multicentre study.
OBJECTIVE
To assess the diagnostic efficacy, safety and tolerability of mangafodipir trisodium (MnDPDP, Teslascan) in MR imaging of the liver.


METHODS
Eighty-two patients from 4 centres underwent MR imaging with pre-contrast sequences including T1-weighted SE and GRE, and T2-weighted turbo SE sequences. MnDPDP at a dose of 5 mumol/kg b.w. was administered by slow i.v. infusion, and 20-60 min after infusion the T1-weighted SE and GRE sequences were repeated. Diagnostic efficacy was evaluated by counting the number of lesions and by evaluating whether more information for lesion characterisation was available in post-contrast images. Safety and tolerability were assessed by recording adverse events and infusion-related discomfort.


RESULTS
Significantly more lesions were found in MnDPDP-enhanced T1-weighted SE and GRE images than in unenhanced images of the same sequences. More lesions were also found in these images compared with T2-weighted images at a level of marginal significance. More information was obtained from MnDPDP-enhanced images in 40 cases. Mild to moderate adverse events were experienced by 17% of the patients.


CONCLUSIONS
MnDPDP-enhanced images can improve lesion detection in the liver and are helpful for lesion characterisation. To obtain optimal diagnostic information of liver lesions T2-weighted images are also valuable. MnDPDP is a safe contrast agent for MR imaging of liver lesions.
Wang
C
C
Department of Diagnostic Radiology, Uppsala University Hospital, Sweden. chen.wang@radiol.uu.se
Ahlström
H
H
Ekholm
S
S
Fagertun
H
H
Hellström
M
M
Hemmingsson
A
A
Holtås
S
S
Isberg
B
B
Jonnson
E
E
Lönnemark-Magnusson
M
M
McGill
S
S
Wallengren
N O
NO
Westman
L
L
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; 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; D008099:Liver / Q000473:pathology*; D008113:Liver Neoplasms / Q000175:diagnosis / Q000556:secondary; D008279:Magnetic Resonance Imaging / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; 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*; D013548:Sweden
D003287:Contrast Media; D008345:Manganese; D011732:Pyridoxal Phosphate; D004492:Edetic Acid; C060076:N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid