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

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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 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
Volume63
Issue number9
Publication statusPublished - 2003 Nov 25

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Keywords

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

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Oncology

Cite this

Shinji, H., Tomoaki, I., Akihiro, T., Yoshinori, I., Junichi, H., Kazuhiro, S., Hiroyoshi, I., Hiroshi, N., Ryohei, K., Takehiko, G., Takamichi, M., Shigeyuki, N., & Taku, S. (2003). Dose investigation of superparamagnetic iron oxide (SPIO) SH U 555 A in liver MR imaging. Nippon Acta Radiologica, 63(9), 539-550.