Improved Characterization of Focal Liver Lesions With Liver-Specific Gadoxetic Acid Disodium-Enhanced Magnetic Resonance Imaging: A Multicenter Phase 3 Clinical Trial
| Autor: | Josy Breuer, David R. Feldman, Jeff L. Fidler, Christopher Leary, Simone Gschwend, Isaac R. Francis, Jeffrey M. Brody, Eric K. Outwater, Richard C. Semelka, Donald G. Mitchell, Kohkan Shamsi, Marco A. Amendola, David A. Bluemke, Dushyant V. Sahani, Jeffrey D. McTavish, Steven S. Raman, Douglas H. Sheafor |
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| Jazyk: | angličtina |
| Rok vydání: | 2010 |
| Předmět: |
Adult
Gadolinium DTPA Male medicine.medical_specialty Gadoxetic acid Phases of clinical research Contrast Media Sensitivity and Specificity Article Lesion Medicine Humans Radiology Nuclear Medicine and imaging Spiral ct medicine.diagnostic_test business.industry Liver Diseases Magnetic resonance imaging respiratory system equipment and supplies Magnetic Resonance Imaging Spiral computed tomography United States Gadoxetic acid disodium respiratory tract diseases Female Radiology Tomography medicine.symptom business Tomography Spiral Computed human activities medicine.drug |
| DOI: | 10.17615/66an-2m16 |
| Popis: | OBJECTIVES To evaluate the safety of gadoxetic acid disodium (Gd-EOB-DTPA) magnetic resonance imaging (MRI) and its efficacy in characterizing liver lesions. METHODS Lesion characterization and classification using combined (unenhanced and Gd-EOB-DTPA-enhanced) MRI were compared with those using unenhanced MRI and contrast-enhanced spiral computed tomography (CT) using on-site clinical and off-site blinded evaluations for patients with focal liver lesions. RESULTS Gadoxetic acid disodium was well tolerated in this study. For the clinical evaluation, more lesions were correctly characterized using combined (unenhanced and Gd-EOB-DTPA-enhanced) MRI than using unenhanced MRI and spiral CT (96% vs 84% and 85%, respectively; P < or = 0.0008). For the blinded evaluation, more lesions were correctly characterized using combined MRI compared with using unenhanced MRI (61%-76% vs 48%-65%, respectively; P < or = 0.0012 for 2/3 readers); when compared with spiral CT, a similar proportion of lesions were correctly characterized. CONCLUSIONS Gadoxetic acid disodium-enhanced MRI is of clinical benefit relative to unenhanced MRI and spiral CT for a radiological diagnosis of liver lesions. |
| Databáze: | OpenAIRE |
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