1. [Clinical application of AMI-25 (superparamagnetic iron oxide) for the MR imaging of hepatic tumors: a multicenter clinical phase III study].
- Author
-
Yoshikawa K, Sasaki Y, Ogawa N, and Sakuma S
- Subjects
- Adolescent, Adult, Aged, Back Pain etiology, Contrast Media, Dextrans, Female, Ferrosoferric Oxide, Headache etiology, Humans, Image Enhancement, Japan, Magnetite Nanoparticles, Male, Middle Aged, Suspensions, Carcinoma, Hepatocellular diagnosis, Iron adverse effects, Liver Neoplasms diagnosis, Magnetic Resonance Imaging, Oxides adverse effects
- Abstract
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.
- Published
- 1994