Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA): a phase II study
| Autor: | Scott D. Flamm, Imre Repa, Jeffrey J. Brown, Herbert Iliasch, Christoph Düber, Kjell Geterud, Manuela Aschauer, Mark E. Lockhart, E. J. R. Van Beek, Michael Stiskal, Jens Rudolf, Steve Wolff, Alain Blum, Thomas C. Yu, Paul Legmann, Thomas Kittner, Werner Judmaier, Peter Reimer, Christiane Blankenstein, Ibone Savalegui, Joan Falco Fages, Bernhard Kramann, Juan Ayuso, Marta Rodriguez Alvares, Allan W. Reid, Harald Ittrich, Eric de Kevviler, Gerda Leisinger |
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| Rok vydání: | 2006 |
| Předmět: |
Adult
Gadolinium DTPA Male medicine.medical_specialty Contrast Media Renal artery stenosis Renal Artery Obstruction Sensitivity and Specificity Magnetic resonance angiography Imaging Three-Dimensional Double-Blind Method Occlusion Image Processing Computer-Assisted Medicine Humans Radiology Nuclear Medicine and imaging Prospective Studies Aged Aged 80 and over medicine.diagnostic_test Dose-Response Relationship Drug business.industry Gadodiamide Angiography Digital Subtraction Magnetic resonance imaging General Medicine Gold standard (test) Digital subtraction angiography Middle Aged medicine.disease Image Enhancement Treatment Outcome Angiography Injections Intravenous Female Radiology Safety business Magnetic Resonance Angiography medicine.drug |
| Zdroj: | European journal of radiology. 64(3) |
| ISSN: | 0720-048X |
| Popis: | Purpose: To determine the most efficacious dose of gadodiamide for three-dimensional (3D) contrast-enhanced (CE) magnetic resonance angiography (MRA) of the renal arteries on a patient level based on the sensitivity in detecting the main hemodynamically relevant (≥50% or occlusion) renal artery stenosis (RAS) using intra-arterial digital subtraction angiography (IA DSA) as the gold standard. Materials and Methods: This prospective, randomized, double-blind, parallel-group, multicenter study included 273 patients referred to IA DSA for suspected RAS. Patients underwent 3D CE MRA after injection of 0.01, 0.05, 0.1, or 0.2 mmol/kg of body weight gadodiamide (0.5 mmol/ml). The images were assessed for location and degree of RAS by independent blinded readers (MRA: three readers, IA DSA: one reader). Hypothesis testing for a significant trend in sensitivity across dose groups was based on the one-sided Cochran-Armitage style trend test for each independent MRA reader. Results: The lowest dose group (0.01 mmol/kg) proved non-efficacious in detecting hemodynamically relevant (i.e., ≥50% or occlusion) RAS. A statistically significant dose trend (p < 0.001) was shown for each of the three independent readers. Depending on reader, the sensitivity obtained with 0.05, 0.1, and 0.2 mmol/kg was 63.9–86.1%, 75.8–91.4% and 80.6–90.6%, the specificity was 66.7–73.9%, 59.3–75.0%, and 59.3–75.0% and accuracy was 67.8–78.9%, 75.4–77.4%, and 76.3–81.0%, for the three dose groups, respectively. There were eight non-severe adverse events (AEs). Three serious AEs occurring in one patient were judged not related to gadodiamide by the on-site investigator. Conclusion: A significant dose trend between the four doses examined was observed. The lowest dose (0.01 mmol/kg) differed significantly from those of the other three doses. Based on the analysis of the primary and secondary endpoints, 0.1 mmol/kg gadodiamide appears to be the most suitable dose in diagnosing hemodynamically relevant RAS. The present study also demonstrated gadodiamide to be safe and well tolerated. © 2007 Elsevier Ireland Ltd. All rights reserved. |
| Databáze: | OpenAIRE |
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