[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.
Yoshikawa
K
K
Department of Radiology, Kanto Rosai Hospital.
Sasaki
Y
Y
Ogawa
N
N
Sakuma
S
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D001416:Back Pain / Q000209:etiology; D006528:Carcinoma, Hepatocellular / Q000175:diagnosis*; D003287:Contrast Media; D003911:Dextrans; D005260:Female; D052203:Ferrosoferric Oxide; D006261:Headache / Q000209:etiology; D006801:Humans; D007089:Image Enhancement; D007501:Iron / Q000009:adverse effects; D007564:Japan; D008113:Liver Neoplasms / Q000175:diagnosis*; D008279:Magnetic Resonance Imaging; D058185:Magnetite Nanoparticles; D008297:Male; D008875:Middle Aged; D010087:Oxides / Q000009:adverse effects; D013535:Suspensions
D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D013535:Suspensions; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide