0000000000803228
AUTHOR
Bernd Tombach
A multicenter, site-independent, blinded study to compare the diagnostic accuracy of contrast-enhanced magnetic resonance angiography using 1.0M gadobutrol (Gadovist) to intraarterial digital subtraction angiography in body arteries.
Abstract Purpose Prospective evaluation of diagnostic accuracy of single field-of-view contrast-enhanced MR Angiography (ceMRA) with 1.0 M gadobutrol compared to intraarterial DSA in body arteries. Materials and methods In an European multicenter study 179 patients underwent ceMRA and DSA. For each indication five prospectively defined vessel segments were evaluated by local investigators onsite and by three site-independent blinded readers (BR) independently. Results The agreement between ceMRA and DSA diagnosis was statistically significant in the onsite (96.6%) and blinded reader (86.6–90.2%) evaluation. Sensitivity, specificity, accuracy, positive (PPV) and negative predictive values (N…
Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions : results of a multicenter, single-blind, interindividual, randomized clinical phase III trial
The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three bli…