MnDPDP for MR imaging of the liver. Results from the European phase III studies.
OBJECTIVE
To evaluate the diagnostic efficacy and safety of MnDPDP (Teslascan) in enhanced MR imaging.


METHODS
In 2 multiple independent trials in Europe 624 patients were given MnDPDP intravenously at 5 mumol/kg b.w. Patients underwent an unenhanced MR examination comprising T1-weighted spin-echo and breath-hold gradient-echo sequences and a T2-weighted spin-echo sequence. The T1 sequences were repeated after the administration of MnDPDP. In a subgroup of 137 patients the results of the enhanced MR images were compared with the results of contrast-enhanced CT (CECT) images.


RESULTS
For both types of T1-weighted sequences and when evaluating the maximum numbers of lesions seen in all imaging sequences, the total numbers of lesions seen were significantly higher in the MnDPDP-enhanced images than in the unenhanced images (p = 0.0005 and p = 0.0001, respectively). The investigators considered the enhanced images to contain "other additional information not found in the unenhanced images" in 279 (45%) of the 621 patients examined. The MnDPDP-enhanced images were also superior to the CECT images in the detection of lesions (p = 0.02). Adverse events were reported by 46 patients (7%) and infusion-associated discomfort by 26 (4%). Heart rates and systolic and diastolic blood pressures showed no clinically significant changes from baseline as a result of the administration of the contrast medium.


CONCLUSIONS
MnDPDP was shown to be effective and safe in enhanced MR imaging of the liver.
Torres
C G
CG
Nycomed Imaging AS, Oslo, Norway. cgt@nycomed.com
Lundby
B
B
Sterud
A T
AT
McGill
S
S
Gordon
P B
PB
Bjerknes
H S
HS
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000009:adverse effects; D004492:Edetic Acid / Q000009:adverse effects / Q000031:analogs & derivatives*; D005060:Europe; D005260:Female; D006801:Humans; D008099:Liver / Q000473:pathology*; D008113:Liver Neoplasms / Q000175:diagnosis; D008279:Magnetic Resonance Imaging / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; D008297:Male; D008345:Manganese / Q000009:adverse effects; D008875:Middle Aged; D011732:Pyridoxal Phosphate / Q000009:adverse effects / Q000031:analogs & derivatives*; D012449:Safety
D003287:Contrast Media; D008345:Manganese; D011732:Pyridoxal Phosphate; D004492:Edetic Acid; C060076:N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid