Abstract
To prospectively evaluate the safety and effectiveness of high doses of 1 mol/L gadobutrol as a contrast agent for computed tomography (CT). Experiments were performed according to guidelines for care of laboratory animals. The local animal care committee approved the study protocol. Unenhanced and contrast material-enhanced CT images of the chest and abdomen were obtained randomly in nine domestic pigs. Gadobutrol was injected (1, 2, or 3 mL per kilogram of body weight; three pigs for each dose). Attenuation was measured in different vascular and parenchymal structures. Changes in blood chemistry and hematologic parameters were monitored before and 1, 2, 3, and 7 days after gadobutrol administration. Urine samples were evaluated before and 7 days after gadobutrol administration. Technetium 99m mertiatide renal scintigraphy was performed before and 7 days after contrast medium injection. Animals were sacrificed 7 days after contrast medium administration, and one kidney was removed from each animal for examination with light microscopy. No serious adverse events occurred. A mixed-model nested analysis of variance was used for statistical evaluation. Mean attenuations for the 1, 2, and 3 mL/kg gadobutrol doses, respectively, were 148 HU +/- 20 (standard deviation), 282 HU +/- 18, and 289 HU +/- 20 in the thoracic aorta; 99 HU +/- 11, 166 HU +/- 9, and 153 HU +/- 18 in the kidneys; and 106 HU +/- 7, 186 HU +/- 18, and 224 HU +/- 24 in the inferior vena cava. No clinically relevant changes in hematologic, blood chemistry, or urine analysis results were detected. Markers for glomerular filtration and tubular function were unaffected in all groups. Scintigraphy revealed no differences between unenhanced and contrast-enhanced results. No morphologic changes of the renal parenchyma were found at histologic analysis. Contrast-enhanced CT with a 2 or 3 mmol/kg dose of 1 mol/L gadobutrol resulted in excellent vascular and parenchymal enhancement. A gadobutrol dose of up to 3 mL/kg did not affect renal function.
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