Dose investigation of superparamagnetic iron oxide (SPIO) SH U 555 A in liver MR imaging

Hirohashi Shinji, Ichikawa Tomoaki, Tanimoto Akihiro, Isobe Yoshinori, Hachiya Junichi, Saito Kazuhiro, Isoda Hiroyoshi, Nishimura Hiroshi, Kuwatsuru Ryohei, Gokan Takehiko, Murakami Takamichi, Nakano Shigeyuki, Seriu Taku

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)


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 μmol Fe/kg) and H dose group (12 μmol 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.

Original languageEnglish
Pages (from-to)539-550
Number of pages12
JournalNippon Acta Radiologica
Issue number9
Publication statusPublished - 2003 Nov 25


  • Contrast media
  • Liver tumor
  • MRI
  • Superparamagnetic iron oxides (SPIO)

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Oncology


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