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

Prospective evaluation of diagnostic accuracy of single field-of-view contrast-enhanced MR Angiography (ceMRA) with 1.0M gadobutrol compared to intraarterial DSA in body arteries. In an European multicenter study 179 patients underwent ceMRA and DSA. For each indication five prospectively defined ve...

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Bibliographic Details
Published in:European journal of radiology 2007-02, Vol.61 (2), p.315-323
Main Authors: Schaefer, Fritz K W, Schaefer, Philipp J, Altjohann, Christian, Bourne, Michael, Decobelli, Francesco, Goyen, Mathias, Griffiths, Paul D, Kopka, Lars, Kreitner, Karl F, Link, Johann, Oberholzer, Katja, Pering, Christiane, Poeckler-Schoeninger, Christiane, Ruehm, Stefan G, Sachoran, Mansur R, Schulte-Altedorneburg, Gernot, Springer, Oliver S, Steiner, Paul, Wall, Alexander, Winterer, Jan, Tombach, Bernd
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Angiography, Digital Subtraction
Arteries - pathology
Constriction, Pathologic - diagnosis
Contrast Media
Gadolinium
Humans
Magnetic Resonance Angiography - methods
Male
Middle Aged
Organometallic Compounds
Prospective Studies
Sensitivity and Specificity
Single-Blind Method
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Summary:Prospective evaluation of diagnostic accuracy of single field-of-view contrast-enhanced MR Angiography (ceMRA) with 1.0M gadobutrol compared to intraarterial DSA in body arteries. 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. 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 (NPV) for detection of relevant stenosis (>50%) were calculated for the right and left internal carotid arteries, and common and external iliac arteries: Sensitivity was 95-98% (onsite) and 76-96% (BR), specificity 94-96% (onsite) and 86-94% (BR), accuracy 96% (onsite) and 87-93% (BR), NPV 98-99% (onsite) and 84-98% (BR), and PPV 79-93% (onsite) and 44-91% (BR), respectively. CeMRA of body arteries using 1.0M gadobutrol provides diagnostic information comparable to intraarterial DSA.
ISSN:0720-048X
DOI:10.1016/j.ejrad.2006.09.002