Dose-toxicity relationship of gadoxetate disodium and transient severe respiratory motion artifact.

Abstract

The purpose of this article is to determine whether there is a dose-toxicity relationship between gadoxetate disodium and transient severe respiratory motion artifact. Gadoxetate disodium-enhanced MRI studies (559 studies of 559 patients) using a fixed 20-mL (2 mL/s; n = 112) or 10-mL (1-2 mL/s; n = 447) volume at two health systems were included (dose range, 0.05-0.42 mL/kg; mean, 0.15 mL/kg; above-label dosing, 479 [86%]). Each dynamic phase was assigned a respiratory motion score from 1 (none) to 5 (nondiagnostic). Examinations with an unenhanced score of 1-2, arterial score of 4-5, and venous or late-dynamic scores of 1-3 were labeled as transient severe respiratory motion artifact. Stepwise multivariate logistic regression was performed. The overall incidence of transient severe respiratory motion artifact was 12% (67/559; site 1, 15% [35/232]; site 2, 9.8% [32/327]). The administered volume of contrast material had a statistically significant effect (20 mL, 20% [22/112] vs 10 mL, 10%, [45/447]; multivariate p = 0.01; odds ratio, 2.1 [20 vs 10 mL]; 95% CI, 1.2-3.7). There was no dose-toxicity relationship for dose-by-weight (p = 0.61 [multivariate]) or above-label dosing (p = 0.88 [univariate]; 13% [10/80] rate for at- or below-label dosing vs 12% [57/479] rate for above-label dosing). Chronic obstructive pulmonary disease was the only non-dose-related predictor in the multivariate model (p < 0.0001; OR, 5.1 [95% CI, 2.5-11.5]; 39% [12/31] vs 10% [55/528]). Gadoxetate disodium-associated transient severe respiratory motion artifact is significantly more common after 20-mL administration (2 mL/s) and occurs significantly more often in patients with chronic obstructive pulmonary disease. The volume-related effect suggests a nonallergiclike mechanism.