Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
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SHR Neuro Krebs Kardio Lipid Stoffw Microb
Kittner, T; Rudolf, J; Fages, JF; Legmann, P; Aschauer, M; Repa, I; Alvares, MR; Savalegui, I; Ittrich, H; Geterud, K; de Kevviler, E; Ayuso, J; Lockhart, ME; Blum, A; Iliasch, H; Leisinger, G; van Beek, EJ; Reid, AW; Brown, JJ; Yu, TC; Flamm, SD; Düber, C; Judmaier, W; Reimer, P; Stiskal, M; Kramann, B; Wolff, S; Blankenstein, C.
Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA): a phase II study.
Eur J Radiol. 2007; 64(3): 456-464.
Doi: 10.1016/j.ejrad.2007.02.034
Web of Science
PubMed
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- Abstract:
- 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 (> or =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 0.2mmol/kg of body weight gadodiamide (0.5mmol/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 (0.01mmol/kg) proved non-efficacious in detecting hemodynamically relevant (i.e., > or =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 0.2mmol/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 (0.01mmol/kg) differed significantly from those of the other three doses. Based on the analysis of the primary and secondary endpoints, 0.1mmol/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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Aged, 80 and over -
- Angiography, Digital Subtraction -
- Contrast Media - administration and dosage
- Dose-Response Relationship, Drug - administration and dosage
- Double-Blind Method - administration and dosage
- Female - administration and dosage
- Gadolinium DTPA - administration and dosage
- Humans - administration and dosage
- Image Enhancement - methods
- Image Processing, Computer-Assisted - methods
- Imaging, Three-Dimensional - methods
- Injections, Intravenous - methods
- Magnetic Resonance Angiography - methods
- Male - methods
- Middle Aged - methods
- Prospective Studies - methods
- Renal Artery Obstruction - diagnosis
- Safety - diagnosis
- Sensitivity and Specificity - diagnosis
- Treatment Outcome - diagnosis
- Find related publications in this database (Keywords)
- renal artery stenosis
- angiography
- magnetic resonance imaging
- digital subtraction angiography
- intra-arterial
- Gd-DTPA-BMA
- clinical trials
- phase II