Eovist (Gadoxetate Disodium) - Summary

EOVIST SUMMARY

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

EOVIST (gadoxetate disodium) is a paramagnetic contrast agent for MRI. EOVIST is provided as a sterile, clear, colorless to pale yellow aqueous solution for intravenous injection.

EOVIST^® Injection is a gadolinium-based contrast agent indicated for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

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NEWS HIGHLIGHTS

Published Studies Related to Eovist (Gadoxetic Acid)

Vascular enhancement in early dynamic liver MR imaging in an animal model: comparison of two injection regimen and two different doses Gd-EOB-DTPA (gadoxetic acid) with standard Gd-DTPA. [2009.06]
OBJECTIVES: To investigate the influence of 2 different doses and injection rates on the enhancement of liver vasculature in Gd-EOB-DTPA enhanced liver MRI compared with the standard dose Gd-DTPA... CONCLUSION: Despite the lower amount of gadolinium in the standard dose of Gd-EOB-DTPA, the results showed that the arterial enhancement in Gd-EOB-DTPA-enhanced dynamic liver MRI was comparable to Gd-DTPA. This result can be explained mainly by the higher relaxivity. Choosing a lower injection rate additionally supported to compensate for the lower injection volume by stretching the bolus without decreasing the peak. In this respect, an injection rate of 1 mL/s showed better results with regard to the arterial enhancement compared with 2 mL/s.

Gadoxetic acid-enhanced MRI versus triple-phase MDCT for the preoperative detection of hepatocellular carcinoma. [2009.06]
CONCLUSION: Gadoxetic acid-enhanced MRI and triple-phase MDCT have similar diagnostic performance in the preoperative detection of HCC, but MRI may be better than MDCT in the detection of HCC 1 cm in diameter or smaller.

Diagnostic efficacy of gadoxetic acid (Primovist)-enhanced MRI and spiral CT for a therapeutic strategy: comparison with intraoperative and histopathologic findings in focal liver lesions. [2008.03]
A multicenter study has been employed to evaluate the diagnostic efficacy of magnetic resonance imaging (MRI) using the new liver-specific contrast agent gadoxetic acid (Gd-EOB-DTPA, Primovist), as opposed to contrast-enhanced biphasic spiral computed tomography (CT), in the diagnosis of focal liver lesions, compared with a standard of reference (SOR)...

MR-guided ablation of hepatocellular carcinoma aided by gadoxetic acid. [2007.06.15]
Local recurrences are problematic following radiofrequency ablation (RFA) of hepatocellular carcinoma.The use of gadoxetic acid disodium, a hepatocyte-specific contrast agent with prolonged retention, is described as a method of improved assessment of the ablative margins relative to the tumor margins.

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Clinical Trials Related to Eovist (Gadoxetic Acid)

Primovist / Eovist in Renally Impaired Patients [Recruiting]
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist.

Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.

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