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J Magn Reson Imaging · Oct 2013
Randomized Controlled Trial Multicenter Study Comparative StudyMulticenter, intra-individual comparison of single dose gadobenate dimeglumine and double dose gadopentetate dimeglumine for MR angiography of the peripheral arteries (the Peripheral VALUE Study).
- Jian Wang, Fuhua Yan, Jianyu Liu, Jianping Lu, Dan Li, Jingyuan Luan, Xiaoying Wang, Yuan Li, Roberto Iezzi, and Francesco De Cobelli.
- Radiology Department, Shanghai Changhai Hospital, Shanghai, China.
- J Magn Reson Imaging. 2013 Oct 1; 38 (4): 926-37.
PurposeTo prospectively compare single dose gadobenate dimeglumine with double dose gadopentetate dimeglumine for CE-MRA in patients with peripheral arterial occlusive disease (PAOD) using an intra-individual crossover study design in which all patients received both contrast agents in otherwise identical CE-MRA examinations.Materials And MethodsInstitutional review board and regulatory approval were granted and all patients provided written informed consent. Sixty-eight patients (53M/15F; 62.4 ± 15.7 years) with mild-to-severe PAOD were enrolled for randomized 3-station CE-MRA with 0.1 mmol/kg gadobenate dimeglumine and 0.2 mmol/kg gadopentetate dimeglumine. Three blinded readers assessed images for vessel anatomical delineation, disease detection/exclusion, and global preference. Diagnostic performance for detection of ≥51% stenosis was determined for 53 patients who underwent DSA. Noninferiority was assessed using the Wilcoxon Signed Rank, McNemar, and Wald tests. Quantitative enhancement was compared.ResultsNo differences (P ≥ 0.25) were noted for any qualitative parameter at any station. Equivalence was reported in at least 62/64 patients (93.8% 3-reader agreement) for diagnostic preference. Superiority for gadobenate dimeglumine was reported by all readers for diagnostic performance (sensitivity: 80.4-88.0% versus 75.2-85.8%; specificity: 89.8-96.0% versus 88.7-94.8%; accuracy: 87.4-91.7% versus 84.9-90.6%; PPV: 84.0-92.8% versus 82.3-90.8%; NPV: 88.5-92.4% versus 85.7-91.1%). Quantitative enhancement was similar in the pelvis but significantly (P < 0.05) greater with gadobenate dimeglumine in the thigh for two readers.ConclusionImage quality and diagnostic performance on peripheral CE-MRA with 0.1 mmol/kg gadobenate dimeglumine is at least equivalent to that with 0.2 mmol/kg gadopentetate dimeglumine.Copyright © 2013 Wiley Periodicals, Inc.
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