title: MnDPDP for MR imaging of the liver. Results from the European phase III studies.
abstract: 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.
authors.affiliation: Nycomed Imaging AS, Oslo, Norway. cgt@nycomed.com
authors.forename: C G
authors.initials: CG
authors.lastname: Torres
authors.forename: B
authors.initials: B
authors.lastname: Lundby
authors.forename: A T
authors.initials: AT
authors.lastname: Sterud
authors.forename: S
authors.initials: S
authors.lastname: McGill
authors.forename: P B
authors.initials: PB
authors.lastname: Gordon
authors.forename: H S
authors.initials: HS
authors.lastname: Bjerknes
mesh_terms: 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
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