[Dose investigation of superparamagnetic iron oxide (SPIO) SH U 555 A in liver MR imaging].
SH U 555 A, a new superparamagnetic iron oxide (SPIO) contrast agent for liver MR imaging, was investigated in terms of safety and efficacy. Eighty-four patients with suspected malignant liver tumor were randomly allocated to two groups: the L dose group (8 mumol Fe/kg) and H dose group (12 mumol Fe/kg). Efficacy was qualitatively evaluated through blinded reading of the MR images. Assessment of the images revealed no consistent differences between the L and H dose groups. During the 3- to 4-day observation period, a total of 16 adverse events were observed in 11 patients: 8 patients in the L dose group and 3 patients in the H dose group. Nasal bleeding occurred in 2 of these cases in the H dose group 2 and 4 days, respectively, after injection. Although patients in the H dose group showed a significantly larger transient decrease in Coagulation Factor XI at 4-6 hr post-injection (p.i.) than patients in the L dose group, analysis of covariance revealed an estimated 6.5% difference. There was no prolongation of APTT or change in Factor XI at 72-96 hr p.i. Because there were no clinically significant differences between the L and H doses, both were considered to be safe and effective.
Hirohashi
Shinji
S
Department of Radiology, Nara Medical University.
Ichikawa
Tomoaki
T
Tanimoto
Akihiro
A
Isobe
Yoshinori
Y
Hachiya
Junichi
J
Saito
Kazuhiro
K
Isoda
Hiroyoshi
H
Nishimura
Hiroshi
H
Kuwatsuru
Ryohei
R
Gokan
Takehiko
T
Murakami
Takamichi
T
Nakano
Shigeyuki
S
Seriu
Taku
T
D000368:Aged; D003287:Contrast Media; D003911:Dextrans; D005260:Female; D052203:Ferrosoferric Oxide; D006801:Humans; D007501:Iron / Q000008:administration & dosage*; D008099:Liver; D008113:Liver Neoplasms / Q000175:diagnosis*; D008279:Magnetic Resonance Imaging; D058185:Magnetite Nanoparticles; D008297:Male; D008875:Middle Aged; D010087:Oxides / Q000008:administration & dosage*; D012449:Safety
D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide