Phase I clinical evaluation of Gd-EOB-DTPA as a hepatobiliary MR contrast agent: safety, pharmacokinetics, and MR imaging.
Radiology
; 195(3): 785-92, 1995 Jun.
Article
en En
| MEDLINE
| ID: mdl-7754011
ABSTRACT
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 ANDMETHODS:
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.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Compuestos Organometálicos
/
Sistema Biliar
/
Imagen por Resonancia Magnética
/
Medios de Contraste
/
Gadolinio DTPA
/
Ácido Pentético
/
Hígado
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Humans
/
Male
Idioma:
En
Revista:
Radiology
Año:
1995
Tipo del documento:
Article
País de afiliación:
Alemania