A multicenter, site-independent, blinded study to compare the diagnostic accuracy of contrast-enhanced magnetic resonance angiography using 1.0 M gadobutrol (Gadovist™) to intraarterial digital subtraction angiography in body arteries

Fritz K W Schaefer, Philipp J. Schaefer, Christian Altjohann, Michael Bourne, Francesco DeCobelli, Mathias Goyen, Paul D. Griffiths, Lars Kopka, Karl F. Kreitner, Johann Link, Katja Oberholzer, Christiane Pering, Christiane Poeckler-Schoeninger, Stefan G. Ruehm, Mansur R. Sachoran, Gernot Schulte-Altedorneburg, Oliver S. Springer, Paul Steiner, Alexander Wall, Jan WintererBernd Tombach

Research output: Contribution to journalArticle

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 (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. Conclusion: CeMRA of body arteries using 1.0 M gadobutrol provides diagnostic information comparable to intraarterial DSA.

Original languageEnglish
Pages (from-to)315-323
Number of pages9
JournalEuropean Journal of Radiology
Volume61
Issue number2
DOIs
Publication statusPublished - Feb 2007

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Digital Subtraction Angiography
Magnetic Resonance Angiography
Angiography
Arteries
Iliac Artery
Internal Carotid Artery
Multicenter Studies
Pathologic Constriction
Research Personnel
Sensitivity and Specificity
gadobutrol

Keywords

  • Contrast media
  • Magnetic resonance angiography
  • Multicenter study

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

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A multicenter, site-independent, blinded study to compare the diagnostic accuracy of contrast-enhanced magnetic resonance angiography using 1.0 M gadobutrol (Gadovist™) to intraarterial digital subtraction angiography in body arteries. / 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.

In: European Journal of Radiology, Vol. 61, No. 2, 02.2007, p. 315-323.

Research output: Contribution to journalArticle

Schaefer, FKW, Schaefer, PJ, Altjohann, C, Bourne, M, DeCobelli, F, Goyen, M, Griffiths, PD, Kopka, L, Kreitner, KF, Link, J, Oberholzer, K, Pering, C, Poeckler-Schoeninger, C, Ruehm, SG, Sachoran, MR, Schulte-Altedorneburg, G, Springer, OS, Steiner, P, Wall, A, Winterer, J & Tombach, B 2007, 'A multicenter, site-independent, blinded study to compare the diagnostic accuracy of contrast-enhanced magnetic resonance angiography using 1.0 M gadobutrol (Gadovist™) to intraarterial digital subtraction angiography in body arteries', European Journal of Radiology, vol. 61, no. 2, pp. 315-323. https://doi.org/10.1016/j.ejrad.2006.09.002
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. / A multicenter, site-independent, blinded study to compare the diagnostic accuracy of contrast-enhanced magnetic resonance angiography using 1.0 M gadobutrol (Gadovist™) to intraarterial digital subtraction angiography in body arteries. In: European Journal of Radiology. 2007 ; Vol. 61, No. 2. pp. 315-323.
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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 (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. Conclusion: CeMRA of body arteries using 1.0 M gadobutrol provides diagnostic information comparable to intraarterial DSA.",
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T1 - A multicenter, site-independent, blinded study to compare the diagnostic accuracy of contrast-enhanced magnetic resonance angiography using 1.0 M gadobutrol (Gadovist™) to intraarterial digital subtraction angiography in body arteries

AU - Schaefer, Fritz K W

AU - Schaefer, Philipp J.

AU - Altjohann, Christian

AU - Bourne, Michael

AU - DeCobelli, Francesco

AU - Goyen, Mathias

AU - Griffiths, Paul D.

AU - Kopka, Lars

AU - Kreitner, Karl F.

AU - Link, Johann

AU - Oberholzer, Katja

AU - Pering, Christiane

AU - Poeckler-Schoeninger, Christiane

AU - Ruehm, Stefan G.

AU - Sachoran, Mansur R.

AU - Schulte-Altedorneburg, Gernot

AU - Springer, Oliver S.

AU - Steiner, Paul

AU - Wall, Alexander

AU - Winterer, Jan

AU - Tombach, Bernd

PY - 2007/2

Y1 - 2007/2

N2 - 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 (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. Conclusion: CeMRA of body arteries using 1.0 M gadobutrol provides diagnostic information comparable to intraarterial DSA.

AB - 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 (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. Conclusion: CeMRA of body arteries using 1.0 M gadobutrol provides diagnostic information comparable to intraarterial DSA.

KW - Contrast media

KW - Magnetic resonance angiography

KW - Multicenter study

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