Radiology, Vol 195, 785-792, Copyright © 1995 by Radiological Society of North America

ARTICLES

Phase I clinical evaluation of Gd-EOB-DTPA as a hepatobiliary MR contrast agent: safety, pharmacokinetics, and MR imaging

B Hamm, T Staks, A Muhler, M Bollow, M Taupitz, T Frenzel, KJ Wolf, HJ Weinmann and L Lange
Department of Radiology, Charite Hospital, Humboldt-Universitat zu Berlin, Germany.

PURPOSE: To determine the safety, pharmacokinetics, and magnetic resonance (MR) imaging results of gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid (Gd-EOB-DTPA) as a contrast agent for use in hepatobiliary MR imaging. MATERIALS AND METHODS: Gd-EOB-DTPA was tested at doses of 10, 25, 50, and 100 mumol per kilogram of body weight. Results of laboratory tests, clinical measurements, and pharmacokinetic data were obtained in 44 healthy volunteers in a double- blind, randomized, placebo-controlled design. MR images were obtained in another 16 healthy volunteers before and up to 6 hours after fast intravenous administration of Gd-EOB-DTPA. RESULTS: Gd-EOB-DTPA was well tolerated, with no important side effects or changes in laboratory parameters. Homogeneous enhancement of liver parenchyma was observed immediately after injection of the contrast agent. Peak liver signal intensity was noted 20 minutes after injection, followed by plateaulike enhancement over about 2 hours. The common bile duct was hyperintense within 10 minutes after injection in all volunteers. CONCLUSION: Gd-EOB- DTPA is safe and efficient for MR imaging of the liver.

This article has been cited by other articles:

				D. A. Bluemke, D. Sahani, M. Amendola, T. Balzer, J. Breuer, J. J. Brown, D. D. Casalino, P. L. Davis, I. R. Francis, G. Krinsky, et al. Efficacy and Safety of MR Imaging with Liver-specific Contrast Agent: U.S. Multicenter Phase III Study Radiology, October 1, 2005; 237(1): 89 - 98. [Abstract] [Full Text] [PDF]

				A. Huppertz, S. Haraida, A. Kraus, C. J. Zech, J. Scheidler, J. Breuer, T. K. Helmberger, and M. F. Reiser Enhancement of Focal Liver Lesions at Gadoxetic Acid-enhanced MR Imaging: Correlation with Histopathologic Findings and Spiral CT--Initial Observations Radiology, February 1, 2005; 234(2): 468 - 478. [Abstract] [Full Text] [PDF]

				A. Huppertz, T. Balzer, A. Blakeborough, J. Breuer, A. Giovagnoni, G. Heinz-Peer, M. Laniado, R. M. Manfredi, D. G. Mathieu, D. Mueller, et al. Improved Detection of Focal Liver Lesions at MR Imaging: Multicenter Comparison of Gadoxetic Acid-enhanced MR Images with Intraoperative Findings Radiology, January 1, 2004; 230(1): 266 - 275. [Abstract] [Full Text] [PDF]

				H. Kobayashi, T. Saga, S. Kawamoto, N. Sato, A. Hiraga, T. Ishimori, J. Konishi, K. Togashi, and M. W. Brechbiel Dynamic Micro-Magnetic Resonance Imaging of Liver Micrometastasis in Mice with a Novel Liver Macromolecular Magnetic Resonance Contrast Agent DAB-Am64-(1B4M-Gd)64 Cancer Res., July 1, 2001; 61(13): 4966 - 4970. [Abstract] [Full Text] [PDF]

				R. C. Semelka and T. K. G. Helmberger Contrast Agents for MR Imaging of the Liver Radiology, January 1, 2001; 218(1): 27 - 38. [Abstract] [Full Text]

				J. Petersein, A. Spinazzi, A. Giovagnoni, P. Soyer, F. Terrier, R. Lencioni, C. Bartolozzi, L. Grazioli, A. Chiesa, R. Manfredi, et al. Focal Liver Lesions: Evaluation of the Efficacy of Gadobenate Dimeglumine in MR Imaging-A Multicenter Phase III Clinical Study Radiology, June 1, 2000; 215(3): 727 - 736. [Abstract] [Full Text]

				J. E. van Montfoort, B. Stieger, D. K. F. Meijer, H.-J. Weinmann, P. J. Meier, and K. E. Fattinger Hepatic Uptake of the Magnetic Resonance Imaging Contrast Agent Gadoxetate by the Organic Anion Transporting Polypeptide Oatp1 J. Pharmacol. Exp. Ther., July 1, 1999; 290(1): 153 - 157. [Abstract] [Full Text]