Safety and efficacy of a novel hepatobiliary MR contrast agent, Gd-DTPA-DeA: Results of phase I and phase II clinical trials

Akihiro Tanimoto, Masumi Kadoya, Yasutaka Kawamura, Ryohei Kuwatsuru, Takehiko Gokan, Shinji Hirohashi

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Abstract

Purpose: To assess the safety, effective dose, and efficacy of a novel hepatobiliary MR contrast agent Gd-DTPA-DeA for imaging liver tumors, from the clinical phase I and phase II trials in Japan. Materials and Methods: In a phase I trial, 33 healthy volunteers were intravenously administered a single dose of 0.03-10 μmol/kg of Gd-DTPA-DeA. In a nationwide phase II trial, 80 patients suspected to have hepatic mass were divided into three dosing groups: 2.5, 5.0, or 7.5 μmol/kg. T1-weighted gradient echo images were obtained before and after Gd-DTPA-DeA administration at three time points. Liver signal-to-noise ratio (SNR) and lesion-liver contrast-to-noise ratio (CNR) were calculated at each time point. A reading committee evaluated the contrast, diagnostic, and overall efficacy using a five-point scale. Results: In a phase I trial, dosages up to 10 μmol/kg were well tolerated by healthy volunteers. In a phase II trial, the contrast, diagnostic, and overall efficacy increased dose-dependently. The overall efficacy was 63.0%, 85.2%, and 88.0%, for 2.5, 5, and 7.5 μmol/kg, respectively. Liver SNR and CNR increase was greater at late phase than at early phase. No serious adverse events occurred. Conclusion: Gd-DTPA-DeA is a well-tolerated and promising contrast agent for liver MR imaging.

Original languageEnglish
Pages (from-to)499-508
Number of pages10
JournalJournal of Magnetic Resonance Imaging
Volume23
Issue number4
DOIs
Publication statusPublished - 2006 Apr 1

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Keywords

  • Contrast media
  • Gadolinium
  • Gd-DTPA-DeA
  • Liver
  • Magnetic resonance imaging
  • Neoplasm

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

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