Multicenter, Double-Blind, Randomized, Intraindividual Crossover Comparison of Gadobenate Dimeglumine and Gadopentetate Dimeglumine for MR Angiography of Peripheral Arteries
Autor: | Angelo Vanzulli, Josef Vymazal, Henrik J. Michaely, Miles A. Kirchin, Claudio Ballarati, Martin N. J. M. Wasser, Gianpaolo Pirovano, Christoph U. Herborn, S.C. Gerretsen, Tim Leiner, Stephan Miller, Siegfried Thurnher, Harald Kramer, Thierry F le Maire |
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Přispěvatelé: | MUMC+: DA BV Medisch Specialisten Radiologie (9), Beeldvorming, RS: CARIM School for Cardiovascular Diseases |
Jazyk: | angličtina |
Rok vydání: | 2010 |
Předmět: |
Adult
Gadolinium DTPA Male medicine.medical_specialty Contrast Media Statistics Nonparametric Magnetic resonance angiography Pelvis Double blind Meglumine Double-Blind Method Peripheral arterial occlusive disease Organometallic Compounds medicine Humans Radiology Nuclear Medicine and imaging Prospective Studies GADOBENATE DIMEGLUMINE Aged Aged 80 and over Peripheral Vascular Diseases magnetic-resonance angiography digital-subtraction-angiography nephrogenic systemic fibrosis aortoiliac occlusive disease dose gadodiamide injection diagnostic performance contrast agents renal-arteries phase-iii 3 tesla Cross-Over Studies medicine.diagnostic_test business.industry Mr angiography Middle Aged Crossover study Peripheral Lower Extremity Female Radiology business Magnetic Resonance Angiography medicine.drug |
Zdroj: | Radiology, 255(3), 988-1000. Radiological Society of North America, Inc. Radiology, 255(3), 988-1000 |
ISSN: | 0033-8419 |
Popis: | Purpose: To prospectively compare the image quality and diagnostic performance achieved with doses of gadobenate dimeglumine and gadopentetate dimeglumine of 0.1 mmol per kilogram of body weight in patients undergoing contrast material-enhanced magnetic resonance (MR) angiography of the pelvis, thigh, and lower-leg (excluding foot) for suspected or known peripheral arterial occlusive disease. Materials and Methods: Institutional review board approval was granted from each center and informed written consent was obtained from all patients. Between November 2006 and January 2008, 96 patients (62 men, 34 women; mean age, 63.7 years +/- 10.4 [standard deviation]; range, 39-86 years) underwent two identical examinations at 1.5 T by using three-dimensional spoiled gradient-echo sequences and randomized 0.1-mmol/kg doses of each agent. Images were evaluated on-site for technical adequacy and quality of vessel visualization and offsite by three independent blinded readers for anatomic delineation and detection/exclusion of pathologic features. Comparative diagnostic performance was determined in 31 patients who underwent digital subtraction angiography. Data were analyzed by using the Wilcoxon signed-rank, McNemar, and Wald tests. Interreader agreement was determined by using generalized k statistics. Differences in quantitative contrast enhancement were assessed and a safety evaluation was performed. Results: Ninety-two patients received both agents. Significantly better performance (P < .0001; all evaluations) with gadobenate dimeglumine was noted on-site for technical adequacy and vessel visualization quality and offsite for anatomic delineation and detection/exclusion of pathologic features. Contrast enhancement (P < .0001) and detection of clinically relevant disease (P < .0028) were significantly improved with gadobenate dimeglumine. Interreader agreement for stenosis detection and grading was good to excellent (k = 0.749 and 0.805, respectively). Mild adverse events were reported for four (six events) and five (eight events) patients after gadobenate dimeglumine and gadopentetate dimeglumine, respectively. Conclusion: Higher- quality vessel visualization, greater contrast enhancement, fewer technical failures, and improved diagnostic performance are obtained with gadobenate dimeglumine, relative to gadopentetate dimeglumine, when compared intraindividually at 0.1-mmol/kg doses in patients undergoing contrast-enhanced MR angiography for suspected peripheral arterial occlusive disease. (c) RSNA, 2010 |
Databáze: | OpenAIRE |
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