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


METHODS
In a phase I trial, 33 healthy volunteers were intravenously administered a single dose of 0.03-10 micromol/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 micromol/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 micromol/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 micromol/kg, respectively. Liver SNR and CNR increase was greater at late phase than at early phase. No serious adverse events occurred.


CONCLUSIONS
Gd-DTPA-DeA is a well-tolerated and promising contrast agent for liver MR imaging.
Tanimoto
Akihiro
A
Department of Diagnostic Radiology, Keio University School of Medicine, Tokyo, Japan. t-mri@tt.rim.or.jp
Kadoya
Masumi
M
Kawamura
Yasutaka
Y
Kuwatsuru
Ryohei
R
Gokan
Takehiko
T
Hirohashi
Shinji
S
D003287:Contrast Media / Q000008:administration & dosage / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D019786:Gadolinium DTPA / Q000008:administration & dosage / Q000493:pharmacokinetics; D006801:Humans; D007564:Japan; D008107:Liver Diseases / Q000175:diagnosis*; D008279:Magnetic Resonance Imaging / Q000379:methods*
D003287:Contrast Media; C073590:gadolinium ethoxybenzyl DTPA; D019786:Gadolinium DTPA