Superparamagnetic iron oxide particles (SH U 555 A): evaluation of efficacy in three doses for hepatic MR imaging

Radiology. 1998 Feb;206(2):365-71. doi: 10.1148/radiology.206.2.9457187.

Abstract

Purpose: To evaluate the efficacy of SH U 555 A in three doses for magnetic resonance (MR) imaging in the liver and to establish the best postinjection time point for liver MR imaging.

Materials and methods: Pre- and postcontrast image sets obtained in 169 patients after injection of SH U 555 A (randomly, 4, 8, or 16 mumol of iron per kilogram of body weight). Three blinded readers evaluated the precontrast and 10- and 40-minute postcontrast MR images of 54, 58, and 57 patients, respectively.

Results: Statistically significant differences were observed in diagnostic confidence between images obtained with a dose of 4 or 16 mumol Fe/kg (P = .011) and in good or excellent improvement, respectively, in delineation of lesions on 10-minute postcontrast images (P = .001). No apparent differences in the efficacy evaluation were seen between the 10- and 40-minute postcontrast imaging time points.

Conclusion: There was a dose-dependent postcontrast improvement in evaluated efficacy parameters (diagnostic confidence, visual evaluations) after injection of SH U 555 A. Accumulation phase imaging could begin as early as 10 minutes after administration.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Contrast Media / administration & dosage*
  • Dextrans
  • Dose-Response Relationship, Drug
  • Evaluation Studies as Topic
  • Female
  • Ferrosoferric Oxide
  • Humans
  • Injections, Intravenous
  • Iron / administration & dosage*
  • Liver / pathology*
  • Liver Diseases / diagnosis
  • Liver Neoplasms / diagnosis*
  • Magnetic Resonance Imaging / methods*
  • Magnetite Nanoparticles
  • Male
  • Middle Aged
  • Oxides / administration & dosage*
  • Suspensions
  • Time Factors

Substances

  • Contrast Media
  • Dextrans
  • Magnetite Nanoparticles
  • Oxides
  • Suspensions
  • Iron
  • ferumoxides
  • Ferrosoferric Oxide