Multicenter, 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, Francesco De Cobelli

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Purpose To 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 Methods Institutional 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. Results No 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. Conclusion Image 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.

Original languageEnglish
Pages (from-to)926-937
Number of pages12
JournalJournal of Magnetic Resonance Imaging
Volume38
Issue number4
DOIs
Publication statusPublished - Oct 2013

Fingerprint

Gadolinium DTPA
Angiography
Arteries
Arterial Occlusive Diseases
Peripheral Arterial Disease
Cross-Over Studies
Research Ethics Committees
Thigh
Informed Consent
Pelvis
Contrast Media
gadobenic acid
Pathologic Constriction

Keywords

  • comparative studies
  • contrast-enhanced MR angiography
  • gadolinium contrast agents
  • peripheral arteries

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

Multicenter, intra-individual comparison of single dose gadobenate dimeglumine and double dose gadopentetate dimeglumine for MR angiography of the peripheral arteries (the Peripheral VALUE Study). / Wang, Jian; Yan, Fuhua; Liu, Jianyu; Lu, Jianping; Li, Dan; Luan, Jingyuan; Wang, Xiaoying; Li, Yuan; Iezzi, Roberto; De Cobelli, Francesco.

In: Journal of Magnetic Resonance Imaging, Vol. 38, No. 4, 10.2013, p. 926-937.

Research output: Contribution to journalArticle

Wang, Jian ; Yan, Fuhua ; Liu, Jianyu ; Lu, Jianping ; Li, Dan ; Luan, Jingyuan ; Wang, Xiaoying ; Li, Yuan ; Iezzi, Roberto ; De Cobelli, Francesco. / Multicenter, intra-individual comparison of single dose gadobenate dimeglumine and double dose gadopentetate dimeglumine for MR angiography of the peripheral arteries (the Peripheral VALUE Study). In: Journal of Magnetic Resonance Imaging. 2013 ; Vol. 38, No. 4. pp. 926-937.
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abstract = "Purpose To 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 Methods Institutional 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. Results No 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. Conclusion Image 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.",
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T1 - Multicenter, intra-individual comparison of single dose gadobenate dimeglumine and double dose gadopentetate dimeglumine for MR angiography of the peripheral arteries (the Peripheral VALUE Study)

AU - Wang, Jian

AU - Yan, Fuhua

AU - Liu, Jianyu

AU - Lu, Jianping

AU - Li, Dan

AU - Luan, Jingyuan

AU - Wang, Xiaoying

AU - Li, Yuan

AU - Iezzi, Roberto

AU - De Cobelli, Francesco

PY - 2013/10

Y1 - 2013/10

N2 - Purpose To 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 Methods Institutional 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. Results No 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. Conclusion Image 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.

AB - Purpose To 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 Methods Institutional 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. Results No 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. Conclusion Image 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.

KW - comparative studies

KW - contrast-enhanced MR angiography

KW - gadolinium contrast agents

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