Premium
Safety and efficacy of a novel hepatobiliary MR contrast agent, Gd‐DTPA‐DeA: Results of phase I and phase II clinical trials
Author(s) -
Tanimoto Akihiro,
Kadoya Masumi,
Kawamura Yasutaka,
Kuwatsuru Ryohei,
Gokan Takehiko,
Hirohashi Shinji
Publication year - 2006
Publication title -
journal of magnetic resonance imaging
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.563
H-Index - 160
eISSN - 1522-2586
pISSN - 1053-1807
DOI - 10.1002/jmri.20543
Subject(s) - medicine , adverse effect , nuclear medicine , dose , clinical trial , clinical endpoint , phases of clinical research , dosing , contrast (vision) , radiology , artificial intelligence , computer science
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. J. Magn. Reson. Imaging 2006. © 2006 Wiley‐Liss, Inc.