Clinical application of AMI-25 (superparamagnetic iron oxide) for the MR imaging of hepatic tumors: a multicenter clinical phase III study

We performed phase III clinical study of AMI-25 (Superparamagnetic iron oxide) for hepatic tumors in 163 cases at the 17 institutions in Japan. In overall evaluation, 141/159 cases (88.7%) were evaluated "useful" or "very useful" for clinical usefulness. For efficacy including the signal to noise ratio (S/N) of liver and the tumor-liver contrast to noise ratio (C/N), 89.6% of hepatocellular carcinomas and 95.0% of metastatic liver cancers were evaluated "effective" or "very effective", respectively. The mild adverse reactions were shown in 10 cases (6.1%), but they disappeared within 25 minutes. The serum iron and ferritin increased and the unsaturated iron binding capacity (UIBC) decreased, but they were showing a tendency to go back to their normal ranges. The AMI-25 (10 mumoles Fe/kg) was proved to be useful and safe contrast agent for the liver tumors in MRI.