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.

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). One hundred and sixty-nine patients with hepatic lesions eligible for surgery underwent Gd-EOB-DTPA-enhanced MRI as well as CT within 6 weeks. Pathologic evaluation of the liver specimen combined with intraoperative ultrasound established the SOR. Data sets were evaluated on-site (14 investigators) and off-site (three independent blinded readers). Gd-EOB-DTPA was well tolerated. Three hundred and two lesions were detected in 131 patients valid for analysis by SOR. The frequency of correctly detected lesions was significantly higher on Gd-EOB-DTPA-enhanced MRI compared with CT in the clinical evaluation [10.44%; 95% confidence interval (CI): 4.88, 16.0]. In the blinded reading there was a trend towards Gd-EOB-DTPA-enhanced MRI, not reaching statistical significance (2.14%; 95% CI: -4.32, 8.6). However, the highest rate of correctly detected lesions with a diameter below 1 cm was achieved by Gd-EOB-DTPA-enhanced MRI. Differential diagnosis was superior for Gd-EOB-DTPA-enhanced MRI (82.1%) versus CT (71.0%). A change in surgical therapy was documented in 19 of 131 patients (14.5%) post Gd-EOB-DTPA-enhanced MRI. Gd-EOB-DTPA-enhanced MRI was superior in the diagnosis and therapeutic management of focal liver lesions compared with CT.

Improved detection of focal liver lesions at MR imaging: multicenter comparison of gadoxetic acid-enhanced MR images with intraoperative findings.

PURPOSE: To evaluate the safety and efficacy of gadoxetic acid disodium-enhanced magnetic resonance (MR) imaging for the detection of focal liver lesions, with results of histopathologic examination and/or intraoperative ultrasonography used as a standard of reference. MATERIALS AND METHODS: One hundred sixty-nine patients who were known to have or suspected of having focal liver lesions and were scheduled for liver surgery were included in this study. Results in 131 patients could be included in the efficacy analysis. MR imaging was performed before and immediately and 20 minutes after bolus injection of 0.025 mmol/kg of the liver-specific hepatobiliary contrast agent gadoxetic acid. T1-weighted gradient-echo (with and without fat saturation and including dynamic data sets) and T2-weighted fast spin-echo/turbo spin-echo sequences were performed. All images were evaluated on site and by three independent and blinded off-site reviewers. Lesion matching based on the standard-of-reference results was performed. Differences in lesion detection with precontrast and with postcontrast MR images were assessed with the two-sided Wilcoxon signed rank test. RESULTS: Gadoxetic acid was well tolerated. In the on-site review, the number of patients in whom all lesions were correctly matched increased from 89 of 129 patients at precontrast MR imaging to 103 of 129 patients at postcontrast MR imaging. In the off-site evaluation, the number of patients in whom all lesions were correctly matched and the corresponding sensitivity values increased from 72 (55.8%), 68 (52.7%), and 66 (51.2%) with the precontrast images to 88 (68.2%), 69 (53.5%), and 76 (58.9%) with the postcontrast images for readers 1, 2, and 3, respectively. Two of the three blinded readers showed a statistically significant difference in lesion detection between precontrast and postcontrast MR imaging (P <.001 and P =.008). A large number of additionally correctly detected and localized lesions were smaller than 1 cm. CONCLUSION: MR imaging with gadoxetic acid is safe and improves lesion detection and localization.