gadoxetic-acid-disodium and Dyspnea

Background Safety data on routine clinical use of gadoxetate disodium for liver magnetic resonance imaging (MRI) is not reported yet. Purpose To assess the safety profile of gadoxetate disodium for liver MRI in the routine clinical setting. Material and Methods Six multicenter studies were performed in Europe, USA, Australia, and Asia to evaluate the safety and efficacy of gadoxetate disodium (Primovist®/Eovist®) enhanced liver MRI. Patients received a single intravenous bolus injection of the standard approved dose of 0.025 mmol/kg body weight (0.1 mL/kg). The number of patients, the characteristics of adverse events, related adverse events, and serious adverse events were analyzed. Results A total of 8194 patients were included in the database. A total of 141 patients (1.7%) reported 230 AEs of which 129 were considered being related to the use of gadoxetate disodium by the investigators. None of the AEs in the pediatric population ( n = 52) were related. The most frequent AEs independent of relationship to the drug included dyspnea (25/0.31%), nausea (22/0.27%), liver disorders (13/0.16%), and renal disorders (9/0.11%). Nine related SAEs were recorded. No patient died during the studies. Conclusion Gadoxetate disodium for liver MRI is safe and well tolerated in the routine clinical setting.

Topics: Adolescent; Adult; Age Distribution; Aged; Chemical and Drug Induced Liver Injury; Child; Child, Preschool; Contrast Media; Drug-Related Side Effects and Adverse Reactions; Dyspnea; Female; Gadolinium DTPA; Humans; Infant; Infant, Newborn; Internationality; Kidney Diseases; Liver Diseases; Magnetic Resonance Imaging; Male; Middle Aged; Nausea; Prevalence; Risk Factors; Sex Distribution; Treatment Outcome; Young Adult

To determine whether acute transient dyspnea and/or arterial phase image degradation occurs more or less often after intravenous administration of gadoxetate disodium than with intravenous administration of gadobenate dimeglumine.. Institutional review board approval and patient consent were obtained for this prospective observational study. One hundred ninety-eight gadolinium-based contrast media administrations (99 with gadoxetate disodium [10 mL, n = 97; 8 mL, n = 1; 16 mL, n = 1] and 99 with gadobenate dimeglumine [0.1 mmol per kilogram of body weight, maximum dose, 20 mL]) for hepatobiliary indications were assessed in 192 patients. Subjective patient complaints were assessed. Objective respiratory motion degradation on T1-weighted precontrast and dynamic postcontrast (arterial, venous, or late dynamic or extracellular) magnetic resonance (MR) imaging datasets were independently assessed in a randomized, blinded fashion by five readers using a five-point scale, with mean scores of 4 or greater indicating severe motion. Comparisons between agents were made by using χ(2) or Fisher exact test, where appropriate.. Significantly more patient complaints of acute transient dyspnea occurred after gadoxetate disodium administration than gadobenate dimeglumine (14% [14 of 99] vs 5% [five of 99], P = .05). There were significantly more severely degraded arterial phase data sets for gadoxetate disodium than for gadobenate dimeglumine for both the general population (17% [17 of 99] vs 2% [two of 99], P = .0007) and the subpopulation with cirrhosis (19% [14 of 72] vs 3% [one of 37], P = .02). This effect did not extend to venous (1% [one of 99] vs 2% [two of 99], P > .99 [overall population]) or late dynamic or extracellular (2% [two of 99] vs 0% [zero of 99], P = .5 [overall population]) phases. No patient required treatment for self-limited dyspnea.. Intravenous gadoxetate disodium can result in acute self-limiting dyspnea that can have a deleterious effect on arterial phase MR image quality and occurs significantly more often than with intravenous gadobenate dimeglumine.

Topics: Adult; Aged; Aged, 80 and over; Artifacts; Chi-Square Distribution; Contrast Media; Dyspnea; Female; Gadolinium DTPA; Humans; Image Interpretation, Computer-Assisted; Injections, Intravenous; Liver Diseases; Magnetic Resonance Imaging; Male; Middle Aged; Prospective Studies

The aims of this study were to objectively evaluate patient respiration and breathing change after contrast injection and to assess its potential impact on image quality for the hepatic arterial phase in gadoxetic acid-enhanced magnetic resonance imaging.. This retrospective study was approved by the institutional review board, and the requirement for informed consent was waived. One hundred fifty-four patients underwent gadoxetic acid-enhanced liver magnetic resonance imaging with a 13-second breath-hold hepatic arterial phase. During the acquisition of precontrast and hepatic arterial phases, the respiratory motion signal was acquired and graded on a 4-point scale based on the SD of the respiratory waveform, with the highest grade indicating the worst breath-hold. Breath-holding grades 3 and 4 for the hepatic arterial phases were considered as breath-holding difficulty during the hepatic arterial phase. Gadoxetic acid-related dyspnea was defined as when the SD value of respiratory waveform during the hepatic arterial phase was 200 greater than that of the precontrast image. Then, the precontrast and hepatic arterial phase images were evaluated with respect to overall image quality and motion artifact using a 5-point scale, with the highest score indicating the worst image quality. In the hepatic arterial phase, the correlation between breath-holding degree and image quality parameters was evaluated using Pearson correlation. The differences in mean image quality scores between patients with and without gadoxetic acid-related dyspnea were evaluated using Student t test.. Based on the analysis of the respiratory waveforms, the incidence of breath-holding difficulty during the hepatic arterial phase was 23.4% (33/154), and the incidence of gadoxetic acid-related dyspnea was 6.5% (10/154). By image analysis, the incidence of a degraded hepatic arterial phase (overall image quality score ≥4) was 5.2% (8/154). During the hepatic arterial phase, the breath-holding degree correlated with overall image quality and motion artifacts (r = 0.564 and 0.578, respectively). Patients with gadoxetic acid-related dyspnea showed significantly worse image qualities of the hepatic arterial phase than patients without gadoxetic acid-related dyspnea (all, P < 0.001), although image qualities for the precontrast image were not statistically significant between the 2 groups (all, P > 0.05).. The objective analysis of respiratory patterns during a breath-hold is feasible and useful for evaluating gadoxetic acid-related dyspnea and its effect on image quality analysis.

Topics: Adult; Aged; Aged, 80 and over; Artifacts; Breath Holding; Contrast Media; Dyspnea; Feasibility Studies; Female; Gadolinium DTPA; History, Ancient; Humans; Image Enhancement; Liver Neoplasms; Magnetic Resonance Imaging; Male; Middle Aged; Motion; Reproducibility of Results; Respiratory Mechanics; Sensitivity and Specificity

To investigate the cause of imaging artifacts observed during gadoxetic acid-enhanced arterial phase imaging of the liver.. This HIPAA-compliant study was approved by the institutional review board. Data were collected prospectively at two sites (site A, United States; site B, Japan) from patients undergoing contrast material-enhanced MR imaging with gadoxetic acid (site A, n = 154, dose = 0.05 mmol/kg; site B, n = 130, 0.025 mmol/kg) or gadobenate dimeglumine (only site A, n = 1666) from January 2014 to September 2014 at site A and from November 2014 to January 2015 at site B. Detailed comparisons between the two agents were made in the patients with dynamic liver acquisitions (n = 372) and age-, sex-, and baseline oxygen saturation (Spo2)-matched pairs (n = 130) at site A. Acquired data included self-reported dyspnea after contrast agent injection, Spo2, and breath-hold fidelity monitored with respiratory bellows.. Self-reported dyspnea was more frequent with gadoxetic acid than with gadobenate dimeglumine (site A, 6.5% [10 of 154] vs 0.1% [two of 1666], P < .001; site B, 1.5% [two of 130]). In the matched-pair comparison, gadoxetic acid, as compared with gadobenate dimeglumine, had higher breath-hold failure rates (site A, 34.6% [45 of 130] vs 11.7% [15 of 130], P < .0001; site B, 16.2% [21 of 130]) and more severe artifacts during arterial phase imaging (site A, 7.7% [10 of 130] vs 0% [none of 130], P < .001; site B, 2.3% [three of 130]). Severe imaging artifacts in patients who received gadoxetic acid were significantly associated with male sex (P = .023), body mass index (P = .021), and breath-hold failure (P < .001) but not with dyspnea or Spo2 decrease.. Severe motion-related artifacts in the arterial phase of gadoxetic acid-enhanced liver MR imaging are associated with breath-hold failure but not with subjective feelings of dyspnea or a substantial decrease in blood Spo2. Subjective feelings of dyspnea are not necessarily associated with imaging artifacts. The phenomenon, albeit at a lower rate, was confirmed at a second site in Japan.

Topics: Adult; Aged; Artifacts; Contrast Media; Dyspnea; Female; Gadolinium DTPA; Humans; Japan; Liver Diseases; Magnetic Resonance Imaging; Male; Meglumine; Middle Aged; Movement; Organometallic Compounds; Prospective Studies; United States

Topics: Artifacts; Attitude of Health Personnel; Contrast Media; Dyspnea; Gadolinium DTPA; Humans; Japan; Magnetic Resonance Imaging; Radiology