MnDPDP for MR imaging of the liver. Results from the European phase III studies.

PURPOSE: To evaluate the diagnostic efficacy and safety of MnDPDP (Teslascan) in enhanced MR imaging. MATERIAL AND 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. CONCLUSION: MnDPDP was shown to be effective and safe in enhanced MR imaging of the liver.

MR imaging properties and pharmacokinetics of MnDPDP in healthy volunteers.

PURPOSE: Thirteen male volunteers were studied to evaluate the MR imaging properties and pharmacokinetics of 10 mM mangafodipir trisodium infusion (MnDPDP, Teslascan). MATERIAL AND METHODS: Doses of 5 and 10 mumol/kg b.w. were administered by bolus injection (< 1 min) to 5 subjects, and by infusion (20 min) to 8 subjects, with a 3-week wash-out between doses. Infusion subjects underwent MR imaging. RESULTS: At 1 h after infusion, the plasma concentration of Mn was reduced to approximately 15% of the maximum value. Fifteen to 20% of Mn was recovered in the urine, and 50-60% was recovered in the faeces. The rapid initial plasma clearance of Mn is consistent with both rapid tissue uptake and rapid renal elimination. Increases in signal intensity were apparent on T1-weighted images of the liver, pancreas, spleen, renal cortex and the renal medulla, but not in regions of the brain protected by an intact blood-brain barrier. Increases were seen in the choroid plexus and pituitary. Contrast-related adverse events, only flushing of moderate intensity, occurred in bolus injection subjects. CONCLUSION: At 5 and 10 mumol/kg, mangafodipir produces relatively long-lasting enhancement of several abdominal organs, including the liver, pancreas and kidney.