gadoxetic-acid-disodium and Body-Weight

The purpose of this study was to identify clinical factors influencing Gd-EOB-DTPA liver uptake in patients with healthy liver parenchyma.. A total of 124 patients underwent contrast-enhanced MRI with a hepatocyte-specific contrast agent at 3 T. T1-weighted volume interpolated breath-hold examination (VIBE) sequences with fat suppression were acquired before and 20 minutes after contrast injection. The relative enhancement (RE) between plain and contrast-enhanced signal intensity was calculated. Simple and multiple linear regression analyses were performed to evaluate clinical factors influencing the relative enhancement. Patients were subdivided into three groups according to their relative liver enhancement (HRE, RE ≥ 100 %; MRE, 100 % > RE > 50 %; NRE, RE ≤ 50 %) and were analyzed according to the relevant risk factors.. Simple regression analyses revealed patient age, transaminases (AST, ALT, GGT), liver, spleen and delta-liver volume (the difference between the volumetrically measured liver volume and the estimated liver volume based on body weight) as significant factors influencing relative enhancement. In the multiple analysis the transaminase AST, spleen and delta liver volume remained significant factors influencing relative enhancement. Delta liver volume showed a significant difference between all analyzed groups.. Liver enhancement in the hepatobiliary phase depends on a variety of factors. Body weight-adapted administration of Gd-EOB-DTPA may lead to inadequate liver enhancement after 20 minutes especially when the actual liver volume differs from the expected volume.. • Differences between actual and expected liver volume can cause inadequate liver enhancement after 20 min. • A liver volume-adapted dose of Gd-EOB-DTPA may help to improve liver enhancement.

Topics: Adult; Aged; Artifacts; Body Weight; Contrast Media; Diagnosis, Differential; Dose-Response Relationship, Drug; Female; Gadolinium DTPA; Humans; Image Enhancement; Liver; Liver Function Tests; Magnetic Resonance Imaging; Male; Middle Aged; Multivariate Analysis; Organ Size; Reference Values; Spleen

To summarize the safety data of gadoxetate disodium, reported in 12 Phase II and III clinical development studies and in the postmarketing surveillance database.. Patients with liver lesions received gadoxetate disodium-enhanced liver magnetic resonance imaging (MRI). Adverse events (AEs) were recorded and evaluated with regard to a potential drug relationship. Subgroup analyses were run on patients with special medical history. Worldwide spontaneous AEs and adverse drug reactions (ADRs) from postmarketing safety surveillance were analyzed.. A total of 1989 patients were included in the clinical development program. A total of 1581/1989 (79.5%) patients received the finally approved dose of 0.025 mmol/kg body weight. 10.1% of patients reported AEs, 4.1% were classified as related AEs. Nausea and headache were the most frequently reported related AEs, with 1.1% each. Age, history of contrast media allergy, liver cirrhosis, or impaired liver or renal function did not significantly impact the frequency and type of AEs. The postmarketing safety surveillance database encompassed more than 2.2 million patients. Nausea was the most frequent ADR, with a reporting rate of 0.00652%; all other symptoms were below 0.004%.. Gadoxetate disodium for liver MRI has an excellent safety profile.

Topics: Adolescent; Adult; Aged, 80 and over; Body Weight; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Contrast Media; Female; Gadolinium DTPA; Humans; Liver; Liver Diseases; Liver Neoplasms; Magnetic Resonance Imaging; Male; Middle Aged; Patient Safety; Product Surveillance, Postmarketing; Young Adult

To clarify the factors that predict enhancement of the liver parenchyma in hepatocyte-phase of gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid (Gd-EOB-DTPA)-enhanced MR imaging.. Gd-EOB-DTPA-enhanced hepatocyte-phase MR images of 198 patients with chronic liver diseases (Child-Pugh class A in 112 patients, class B in 74 patients, and class C in 12 patients) were retrospectively analyzed. The hepatocyte-phase images were obtained using fat-suppressed T1-weighted gradient-echo images with a 3D acquisition sequence 10 min and 20 min after IV administration of Gd-EOB-DTPA (0.025 mmol/kg body weight). The quantitative liver-spleen contrast ratio (Q-LSC) was calculated using the signal intensities of the liver and spleen. Serum albumin levels, total bilirubin levels, prothrombin activity, and the results of indocyanine green clearance tests (ICGs) were recorded and correlated with the Q-LSC. Logistic regression analysis was performed to analyze which factors predict sufficient liver enhancement using a Q-LSC of 1.5 as a cutoff value.. Only ICGs and Child-Pugh classifications showed a statistically significant correlation with the Q-LSC. Logistic regression analysis showed that ICGs were the only factors that accurately predicted liver enhancement on hepatocyte-phase images.. ICGs were found to be predictors of sufficient liver enhancement on hepatocyte-phase images.

Topics: Adult; Aged; Aged, 80 and over; Biomarkers; Body Weight; Contrast Media; Female; Gadolinium DTPA; Hepatocytes; Humans; Liver; Magnetic Resonance Imaging; Male; Middle Aged; Regression Analysis