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MR angiography at 3 T of peripheral arterial disease: a randomized prospective comparison of gadoterate meglumine and gadobutrol
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| Veröffentlicht in: | American journal of roentgenology 204(2015), 6, Seite 1311-1321 |
|---|---|
| Personen und Körperschaften: | , |
| Titel: | MR angiography at 3 T of peripheral arterial disease: a randomized prospective comparison of gadoterate meglumine and gadobutrol/ Christian Loewe, Javier Arnaiz, Denis Krause, Luis Marti-Bonmati, Stefan Haneder, Ulrich Kramer, for the DALIA study group |
| Format: | E-Book-Kapitel |
| Sprache: | Englisch |
| veröffentlicht: |
June 2015
|
| Gesamtaufnahme: |
: American journal of roentgenology, 204(2015), 6, Seite 1311-1321
, volume:204 |
| Schlagwörter: | |
| Quelle: | Verbunddaten SWB Lizenzfreie Online-Ressourcen |
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| 245 | 1 | 0 | |a MR angiography at 3 T of peripheral arterial disease |b a randomized prospective comparison of gadoterate meglumine and gadobutrol |c Christian Loewe, Javier Arnaiz, Denis Krause, Luis Marti-Bonmati, Stefan Haneder, Ulrich Kramer, for the DALIA study group |
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| 520 | |a Objective: This large-scale randomized study aimed to show the noninferiority in terms of diagnostic performance of gadoterate meglumine-enhanced versus gadobutrol-enhanced 3-T MR angiography (MRA) using digital subtraction angiography (DSA) as the reference standard in patients with peripheral arterial occlusive disease (PAOD). Subjects and methods: In this prospective international randomized double-blind phase IV trial, 189 patients were enrolled. Of them, 156 could be included in the per-protocol population for on-site assessments and 154 for off-site readings. Subjects underwent peripheral MRA, after injection of 0.1 mmol/kg of either gadoterate meglumine or gadobutrol, and DSA within 30 days. The diagnostic accuracy was evaluated and compared using a noninferiority analysis. Secondary endpoints included sensitivity, specificity, diagnostic confidence, contrast-to-noise ratio, and signal-to-noise ratio evaluations. Results: The percentage agreement between MRA and DSA for stenosis detection was similar for on-site readings for both groups (mean ± SD, 80.6% ± 16.1% with gadoterate meglumine vs 77.1% ± 19.6% with gadobutrol; 3.5% difference), and the same was true for off-site readings (73.9% ± 16.9% with gadoterate meglumine vs 75.1% ± 13.8% with gadobutrol; 1.1% difference). The noninferiority of gadoterate meglumine to gadobutrol was shown for both on- and off-site readings. Sensitivity in detecting significant stenosis (> 50%) was 72.3% for gadoterate meglumine versus 70.6% for gadobutrol, whereas specificity (92.6% vs 92.3%), diagnostic confidence (87.0% vs 86.0%), signal-to-noise ratio (165.5 vs 161.0), and contrast-to-noise ratio (159.5 vs 155.3) did not differ statistically significantly between the two groups. Conclusion: Gadoterate meglumine was found to be not inferior to gadobutrol in terms of diagnostic performance in patients with PAOD undergoing 3-T contrast-enhanced MRA. No statistically significant differences were detected between the two MRA groups. | ||
| 650 | 4 | |a 3 T | |
| 650 | 4 | |a gadobutrol | |
| 650 | 4 | |a gadoterate meglumine | |
| 650 | 4 | |a MR angiography | |
| 650 | 4 | |a peripheral arterial occlusive disease | |
| 700 | 1 | |a Haneder, Stefan |d 1981- |e VerfasserIn |0 (DE-588)136678335 |0 (DE-627)585462097 |0 (DE-576)287960943 |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t American journal of roentgenology |d Leesburg, Va. : American Roentgen Ray Society, 1965 |g 204(2015), 6, Seite 1311-1321 |h Online-Ressource |w (DE-627)320501086 |w (DE-600)2012224-X |w (DE-576)094113602 |x 1546-3141 |7 nnns |
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| contents | Objective: This large-scale randomized study aimed to show the noninferiority in terms of diagnostic performance of gadoterate meglumine-enhanced versus gadobutrol-enhanced 3-T MR angiography (MRA) using digital subtraction angiography (DSA) as the reference standard in patients with peripheral arterial occlusive disease (PAOD). Subjects and methods: In this prospective international randomized double-blind phase IV trial, 189 patients were enrolled. Of them, 156 could be included in the per-protocol population for on-site assessments and 154 for off-site readings. Subjects underwent peripheral MRA, after injection of 0.1 mmol/kg of either gadoterate meglumine or gadobutrol, and DSA within 30 days. The diagnostic accuracy was evaluated and compared using a noninferiority analysis. Secondary endpoints included sensitivity, specificity, diagnostic confidence, contrast-to-noise ratio, and signal-to-noise ratio evaluations. Results: The percentage agreement between MRA and DSA for stenosis detection was similar for on-site readings for both groups (mean ± SD, 80.6% ± 16.1% with gadoterate meglumine vs 77.1% ± 19.6% with gadobutrol; 3.5% difference), and the same was true for off-site readings (73.9% ± 16.9% with gadoterate meglumine vs 75.1% ± 13.8% with gadobutrol; 1.1% difference). The noninferiority of gadoterate meglumine to gadobutrol was shown for both on- and off-site readings. Sensitivity in detecting significant stenosis (> 50%) was 72.3% for gadoterate meglumine versus 70.6% for gadobutrol, whereas specificity (92.6% vs 92.3%), diagnostic confidence (87.0% vs 86.0%), signal-to-noise ratio (165.5 vs 161.0), and contrast-to-noise ratio (159.5 vs 155.3) did not differ statistically significantly between the two groups. Conclusion: Gadoterate meglumine was found to be not inferior to gadobutrol in terms of diagnostic performance in patients with PAOD undergoing 3-T contrast-enhanced MRA. No statistically significant differences were detected between the two MRA groups. |
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| spelling | Loewe, Christian 1971- VerfasserIn (DE-588)1150170719 (DE-627)1010342290 (DE-576)496926314 aut, MR angiography at 3 T of peripheral arterial disease a randomized prospective comparison of gadoterate meglumine and gadobutrol Christian Loewe, Javier Arnaiz, Denis Krause, Luis Marti-Bonmati, Stefan Haneder, Ulrich Kramer, for the DALIA study group, June 2015, 11, Text txt rdacontent, Computermedien c rdamedia, Online-Ressource cr rdacarrier, Gesehen am 08.01.2018, Objective: This large-scale randomized study aimed to show the noninferiority in terms of diagnostic performance of gadoterate meglumine-enhanced versus gadobutrol-enhanced 3-T MR angiography (MRA) using digital subtraction angiography (DSA) as the reference standard in patients with peripheral arterial occlusive disease (PAOD). Subjects and methods: In this prospective international randomized double-blind phase IV trial, 189 patients were enrolled. Of them, 156 could be included in the per-protocol population for on-site assessments and 154 for off-site readings. Subjects underwent peripheral MRA, after injection of 0.1 mmol/kg of either gadoterate meglumine or gadobutrol, and DSA within 30 days. The diagnostic accuracy was evaluated and compared using a noninferiority analysis. Secondary endpoints included sensitivity, specificity, diagnostic confidence, contrast-to-noise ratio, and signal-to-noise ratio evaluations. Results: The percentage agreement between MRA and DSA for stenosis detection was similar for on-site readings for both groups (mean ± SD, 80.6% ± 16.1% with gadoterate meglumine vs 77.1% ± 19.6% with gadobutrol; 3.5% difference), and the same was true for off-site readings (73.9% ± 16.9% with gadoterate meglumine vs 75.1% ± 13.8% with gadobutrol; 1.1% difference). The noninferiority of gadoterate meglumine to gadobutrol was shown for both on- and off-site readings. Sensitivity in detecting significant stenosis (> 50%) was 72.3% for gadoterate meglumine versus 70.6% for gadobutrol, whereas specificity (92.6% vs 92.3%), diagnostic confidence (87.0% vs 86.0%), signal-to-noise ratio (165.5 vs 161.0), and contrast-to-noise ratio (159.5 vs 155.3) did not differ statistically significantly between the two groups. Conclusion: Gadoterate meglumine was found to be not inferior to gadobutrol in terms of diagnostic performance in patients with PAOD undergoing 3-T contrast-enhanced MRA. No statistically significant differences were detected between the two MRA groups., 3 T, gadobutrol, gadoterate meglumine, MR angiography, peripheral arterial occlusive disease, Haneder, Stefan 1981- VerfasserIn (DE-588)136678335 (DE-627)585462097 (DE-576)287960943 aut, Enthalten in American journal of roentgenology Leesburg, Va. : American Roentgen Ray Society, 1965 204(2015), 6, Seite 1311-1321 Online-Ressource (DE-627)320501086 (DE-600)2012224-X (DE-576)094113602 1546-3141 nnns, volume:204 year:2015 number:6 pages:1311-1321 extent:11, http://dx.doi.org/10.2214/AJR.14.12604 Verlag Resolving-System kostenfrei Volltext, https://www-ajronline-org.ezproxy.medma.uni-heidelberg.de/doi/10.2214/AJR.14.12604 Verlag kostenfrei Volltext, http://dx.doi.org/10.2214/AJR.14.12604 LFER, LFER 2018-09-13T00:00:00Z |
| spellingShingle | Loewe, Christian, Haneder, Stefan, MR angiography at 3 T of peripheral arterial disease: a randomized prospective comparison of gadoterate meglumine and gadobutrol, Objective: This large-scale randomized study aimed to show the noninferiority in terms of diagnostic performance of gadoterate meglumine-enhanced versus gadobutrol-enhanced 3-T MR angiography (MRA) using digital subtraction angiography (DSA) as the reference standard in patients with peripheral arterial occlusive disease (PAOD). Subjects and methods: In this prospective international randomized double-blind phase IV trial, 189 patients were enrolled. Of them, 156 could be included in the per-protocol population for on-site assessments and 154 for off-site readings. Subjects underwent peripheral MRA, after injection of 0.1 mmol/kg of either gadoterate meglumine or gadobutrol, and DSA within 30 days. The diagnostic accuracy was evaluated and compared using a noninferiority analysis. Secondary endpoints included sensitivity, specificity, diagnostic confidence, contrast-to-noise ratio, and signal-to-noise ratio evaluations. Results: The percentage agreement between MRA and DSA for stenosis detection was similar for on-site readings for both groups (mean ± SD, 80.6% ± 16.1% with gadoterate meglumine vs 77.1% ± 19.6% with gadobutrol; 3.5% difference), and the same was true for off-site readings (73.9% ± 16.9% with gadoterate meglumine vs 75.1% ± 13.8% with gadobutrol; 1.1% difference). The noninferiority of gadoterate meglumine to gadobutrol was shown for both on- and off-site readings. Sensitivity in detecting significant stenosis (> 50%) was 72.3% for gadoterate meglumine versus 70.6% for gadobutrol, whereas specificity (92.6% vs 92.3%), diagnostic confidence (87.0% vs 86.0%), signal-to-noise ratio (165.5 vs 161.0), and contrast-to-noise ratio (159.5 vs 155.3) did not differ statistically significantly between the two groups. Conclusion: Gadoterate meglumine was found to be not inferior to gadobutrol in terms of diagnostic performance in patients with PAOD undergoing 3-T contrast-enhanced MRA. No statistically significant differences were detected between the two MRA groups., 3 T, gadobutrol, gadoterate meglumine, MR angiography, peripheral arterial occlusive disease |
| swb_id_str | 496928783 |
| title | MR angiography at 3 T of peripheral arterial disease: a randomized prospective comparison of gadoterate meglumine and gadobutrol |
| title_auth | MR angiography at 3 T of peripheral arterial disease a randomized prospective comparison of gadoterate meglumine and gadobutrol |
| title_full | MR angiography at 3 T of peripheral arterial disease a randomized prospective comparison of gadoterate meglumine and gadobutrol Christian Loewe, Javier Arnaiz, Denis Krause, Luis Marti-Bonmati, Stefan Haneder, Ulrich Kramer, for the DALIA study group |
| title_fullStr | MR angiography at 3 T of peripheral arterial disease a randomized prospective comparison of gadoterate meglumine and gadobutrol Christian Loewe, Javier Arnaiz, Denis Krause, Luis Marti-Bonmati, Stefan Haneder, Ulrich Kramer, for the DALIA study group |
| title_full_unstemmed | MR angiography at 3 T of peripheral arterial disease a randomized prospective comparison of gadoterate meglumine and gadobutrol Christian Loewe, Javier Arnaiz, Denis Krause, Luis Marti-Bonmati, Stefan Haneder, Ulrich Kramer, for the DALIA study group |
| title_in_hierarchy | MR angiography at 3 T of peripheral arterial disease: a randomized prospective comparison of gadoterate meglumine and gadobutrol / Christian Loewe, Javier Arnaiz, Denis Krause, Luis Marti-Bonmati, Stefan Haneder, Ulrich Kramer, for the DALIA study group, |
| title_short | MR angiography at 3 T of peripheral arterial disease |
| title_sort | mr angiography at 3 t of peripheral arterial disease a randomized prospective comparison of gadoterate meglumine and gadobutrol |
| title_sub | a randomized prospective comparison of gadoterate meglumine and gadobutrol |
| topic | 3 T, gadobutrol, gadoterate meglumine, MR angiography, peripheral arterial occlusive disease |
| topic_facet | 3 T, gadobutrol, gadoterate meglumine, MR angiography, peripheral arterial occlusive disease |
| url | http://dx.doi.org/10.2214/AJR.14.12604, https://www-ajronline-org.ezproxy.medma.uni-heidelberg.de/doi/10.2214/AJR.14.12604 |