Gd-EOB-DTPA (EovistO), A Liver Specific Contrast Agent For MRI: Results of a Placebo Controlled, Double Blind Dose Ranging Study in Patients with Focal Hepatic Lesions

The objective of this study was to determine the diagnostic efficacy and safety of Gd-EOB-DTPA (Eovista) at 4 doses (3.0; 6.0; 12.5 and 25 pmol Gd-EOB-DTPNkg BW [body weight]) as compared to placebo (0.9% salinc) in patients with known focal liver lesion(s) A total of 171 received contrast medium injection or placebo (0.9% salinc) Thirty five patients received placebo, 33 patients receivcd 3, 32 received 6, 34 patients received 12.5 and 35 patients receivcd 25 pmol Gd-EOB-DTPN kg BW in randomized manner. Conclusions: Cd-EOB-DTPA is a safe contrast nicdium. The optimum dose is 25 pmol ikg BW. Common noninvasive techniques to evaluate liver are ultrasound, CT and MRI Among these noninvasive modalities, MRI has shown ( I ) to possess the highest sensitivity and specificity, which still can be improved by the application of various types of contrast media. Examples of liver specific agents include FeridexO and TeslascanO. Gd-EOB-DTPA is a new liver specific contrast agent being developed by Schering AG, BerliniGermany. The bolus applicable Gd-EOBDTPA, a hepatobiliary contrast agent is an ethoxybenzyl (lipophilic) derivative of Gd-DTPA. Gd-EOB-DTPA has about 10 % protein binding and through the active carrier mediatcd transportation is takcn up by hepatocytes. This leads to a distribution both into the extracellular space (similar to extracellular contrast agents) and uptake by hepatocytes. This unique property is utilized for liver MRI by performing dynamic imaging during perfusion phasc and hepatocyte phasc imaging thereafter. The hepatocyte uptake increases the signal intensity of normal hepatic parenchyma thereby increasing lesion-toliver-contrast that is the basis of improving lesion detection. As hepatocyte uptake of Gd-EOB-DTPA is dcpendcnt on prescncei absencc of functional hepatocytes, hepatocyte phase imaging also provides functional information within the tumors that aids in tissue characterization. Cd-EOB-DTPA is completely eliminated from body by excretion through renal and biliary route (about 50% biliary and about 50 % renally) (2) TI relaxivity is nearly double than that of conventional "exti-acellular" gadolinium chelates. Study objectives: The objcctive of this study was to detcrminc the diagnostic efficacy and safety of Gd-EOB-DTPA at 4 doses (3.0; 6.0; 12.5 and 25 pmol Gd-EOB-DTPNkg BW [body weight]) as compared to placebo (0.9% saline) in patients with known focal liver