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


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.


CONCLUSIONS
Gd-EOB-DTPA is safe and efficient for MR imaging of the liver.
Hamm
B
B
Department of Radiology, Charité Hospital, Humboldt-Universität zu Berlin, Germany.
Staks
T
T
Mühler
A
A
Bollow
M
M
Taupitz
M
M
Frenzel
T
T
Wolf
K J
KJ
Weinmann
H J
HJ
Lange
L
L
D000328:Adult; D001659:Biliary Tract / Q000033:anatomy & histology*; D003287:Contrast Media / Q000009:adverse effects / Q000493:pharmacokinetics; D004311:Double-Blind Method; D019786:Gadolinium DTPA; D006801:Humans; D008099:Liver / Q000033:anatomy & histology*; D008279:Magnetic Resonance Imaging; D008297:Male; D009942:Organometallic Compounds / Q000009:adverse effects / Q000493:pharmacokinetics; D004369:Pentetic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics
D003287:Contrast Media; D009942:Organometallic Compounds; C073590:gadolinium ethoxybenzyl DTPA; D004369:Pentetic Acid; D019786:Gadolinium DTPA