title: [Dose investigation of superparamagnetic iron oxide (SPIO) SH U 555 A in liver MR imaging].
abstract: 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.
authors.affiliation: Department of Radiology, Nara Medical University.
authors.forename: Shinji
authors.initials: S
authors.lastname: Hirohashi
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Ichikawa
authors.forename: Akihiro
authors.initials: A
authors.lastname: Tanimoto
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Isobe
authors.forename: Junichi
authors.initials: J
authors.lastname: Hachiya
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Saito
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Isoda
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nishimura
authors.forename: Ryohei
authors.initials: R
authors.lastname: Kuwatsuru
authors.forename: Takehiko
authors.initials: T
authors.lastname: Gokan
authors.forename: Takamichi
authors.initials: T
authors.lastname: Murakami
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Nakano
authors.forename: Taku
authors.initials: T
authors.lastname: Seriu
mesh_terms: 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
chemical_list: D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide