MNDPDP FOR MR-IMAGING OF THE LIVER - RESULTS FROM THE EUROPEAN PHASE-III STUDIES

Purpose: To evaluate the diagnostic efficacy and safety of MnDPDP (Tes lascan) in enhanced MR imaging. Material and Methods: In 2 multiple in dependent trials in Europe 624 patients were given MnDPDP intravenousl y at 5 mu mol/kg b.w. Patients underwent an unenhanced MR examination comprising T1-weighted spin-echo and breath-hold gradient-echo sequenc es and a T2-weighted spin-echo sequence. The T1 sequences were repeate d after the administration of MnDPDP. In a subgroup of 137 patients th e results of the enhanced MR images were compared with the results of contrast-enhanced CT (CECT) images. Results: For both types of T1-weig hted sequences and when evaluating the maxi mum numbers of lesions see n in all imaging sequences, the total numbers of lesions seen were sig nificantly higher in the MnDPDP-enhanced images than in the unenhanced images (p=0.0005 and p=0.0001, respectively). The investigators consi dered the enhanced images to contain ''other additional information no t found in the unenhanced images'' in 279 (45%) of the 621 patients ex amined. The MnDPDP-enhanced images were also superior to the CECT imag es in the detection of lesions (p=0.02). Adverse events were reported by 46 patients (7%) and infusion-associated discomfort by 26 (4%). Hea rt rates and systolic and diastolic blood pressures showed no clinical ly 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.