Contrast enhancement of central nervous system lesions: Multicenter intraindividual crossover comparative study of two MR contrast agents

Kenneth R. Maravilla, Joseph A Maldjian, Ilona M. Schmalfuss, Matthew J. Kuhn, Brian C. Bowen, Franz J. Wippold, Val M. Runge, Michael V. Knopp, Stephane Kremer, Leo J. Wolansky, Nicoletta Anzalone, Marco Essig, Lars Gustafsson

Research output: Contribution to journalReview article

65 Citations (Scopus)

Abstract

Purpose: To prospectively compare gadobenate dimeglumine with gadopentetate dimeglumine (0.1 mmol per kilogram body weight) for enhanced magnetic resonance (MR) imaging of central nervous system (CNS) lesions. Materials and Methods: This study was HIPAA-compliant at U.S. centers and was conducted at all centers according to the Good Clinical Practice standard. Institutional review board and regulatory approval were granted; written informed consent was obtained. Seventy-nine men and 78 women (mean age, 50.5 years ± 14.4 [standard deviation]) were randomized to group A (n = 78) or B (n = 79). Patients underwent two temporally separated 1.5-T MR imaging examinations. In randomized order, gadobenate followed by gadopentetate was administered, in group A; order of administration was reversed in group B. Contrast agent administration (volume, speed of injection), imaging parameters before and after injection, and time between injections and postinjection acquisitions were identical for both examinations. Three blinded neuroradiologists evaluated images by using objective image interpretation criteria for diagnostic information end points (lesion border delineation, definition of disease extent, visualization of internal morphologic features of the lesion, enhancement of the lesion) and quantitative parameters (percentage of lesion enhancement, contrast-to-noise ratio [CNR]). Overall diagnostic preference in terms of lesion conspicuity, detectability, and diagnostic confidence was assessed. Between-group comparisons were performed with Wilcoxon signed rank test. Results: Readers 1, 2, and 3 demonstrated overall preference for gadobenate in 75, 89, and 103 patients, compared with that for gadopentetate in seven, 10, and six patients, respectively (P < .0001). Significant (P < .0001) preference for gadobenate was demonstrated for diagnostic information end points, percentage of lesion enhancement, and CNR. Superiority of gadobenate was significant (P < .001) in patients with intraaxial and extraaxial lesions. Conclusion: Gadobenate compared with gadopentetate at an equivalent dose provides significantly better enhancement and diagnostic information for CNS MR imaging.

Original languageEnglish (US)
Pages (from-to)389-400
Number of pages12
JournalRadiology
Volume240
Issue number2
DOIs
StatePublished - Aug 1 2006

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Cross-Over Studies
Contrast Media
Magnetic Resonance Spectroscopy
Central Nervous System
Magnetic Resonance Imaging
Injections
Noise
Health Insurance Portability and Accountability Act
Gadolinium DTPA
Research Ethics Committees
Nonparametric Statistics
Informed Consent
Body Weight

ASJC Scopus subject areas

  • Radiological and Ultrasound Technology

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Contrast enhancement of central nervous system lesions : Multicenter intraindividual crossover comparative study of two MR contrast agents. / Maravilla, Kenneth R.; Maldjian, Joseph A; Schmalfuss, Ilona M.; Kuhn, Matthew J.; Bowen, Brian C.; Wippold, Franz J.; Runge, Val M.; Knopp, Michael V.; Kremer, Stephane; Wolansky, Leo J.; Anzalone, Nicoletta; Essig, Marco; Gustafsson, Lars.

In: Radiology, Vol. 240, No. 2, 01.08.2006, p. 389-400.

Research output: Contribution to journalReview article

Maravilla, KR, Maldjian, JA, Schmalfuss, IM, Kuhn, MJ, Bowen, BC, Wippold, FJ, Runge, VM, Knopp, MV, Kremer, S, Wolansky, LJ, Anzalone, N, Essig, M & Gustafsson, L 2006, 'Contrast enhancement of central nervous system lesions: Multicenter intraindividual crossover comparative study of two MR contrast agents', Radiology, vol. 240, no. 2, pp. 389-400. https://doi.org/10.1148/radiol.2402051266
Maravilla, Kenneth R. ; Maldjian, Joseph A ; Schmalfuss, Ilona M. ; Kuhn, Matthew J. ; Bowen, Brian C. ; Wippold, Franz J. ; Runge, Val M. ; Knopp, Michael V. ; Kremer, Stephane ; Wolansky, Leo J. ; Anzalone, Nicoletta ; Essig, Marco ; Gustafsson, Lars. / Contrast enhancement of central nervous system lesions : Multicenter intraindividual crossover comparative study of two MR contrast agents. In: Radiology. 2006 ; Vol. 240, No. 2. pp. 389-400.
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abstract = "Purpose: To prospectively compare gadobenate dimeglumine with gadopentetate dimeglumine (0.1 mmol per kilogram body weight) for enhanced magnetic resonance (MR) imaging of central nervous system (CNS) lesions. Materials and Methods: This study was HIPAA-compliant at U.S. centers and was conducted at all centers according to the Good Clinical Practice standard. Institutional review board and regulatory approval were granted; written informed consent was obtained. Seventy-nine men and 78 women (mean age, 50.5 years ± 14.4 [standard deviation]) were randomized to group A (n = 78) or B (n = 79). Patients underwent two temporally separated 1.5-T MR imaging examinations. In randomized order, gadobenate followed by gadopentetate was administered, in group A; order of administration was reversed in group B. Contrast agent administration (volume, speed of injection), imaging parameters before and after injection, and time between injections and postinjection acquisitions were identical for both examinations. Three blinded neuroradiologists evaluated images by using objective image interpretation criteria for diagnostic information end points (lesion border delineation, definition of disease extent, visualization of internal morphologic features of the lesion, enhancement of the lesion) and quantitative parameters (percentage of lesion enhancement, contrast-to-noise ratio [CNR]). Overall diagnostic preference in terms of lesion conspicuity, detectability, and diagnostic confidence was assessed. Between-group comparisons were performed with Wilcoxon signed rank test. Results: Readers 1, 2, and 3 demonstrated overall preference for gadobenate in 75, 89, and 103 patients, compared with that for gadopentetate in seven, 10, and six patients, respectively (P < .0001). Significant (P < .0001) preference for gadobenate was demonstrated for diagnostic information end points, percentage of lesion enhancement, and CNR. Superiority of gadobenate was significant (P < .001) in patients with intraaxial and extraaxial lesions. Conclusion: Gadobenate compared with gadopentetate at an equivalent dose provides significantly better enhancement and diagnostic information for CNS MR imaging.",
author = "Maravilla, {Kenneth R.} and Maldjian, {Joseph A} and Schmalfuss, {Ilona M.} and Kuhn, {Matthew J.} and Bowen, {Brian C.} and Wippold, {Franz J.} and Runge, {Val M.} and Knopp, {Michael V.} and Stephane Kremer and Wolansky, {Leo J.} and Nicoletta Anzalone and Marco Essig and Lars Gustafsson",
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T1 - Contrast enhancement of central nervous system lesions

T2 - Multicenter intraindividual crossover comparative study of two MR contrast agents

AU - Maravilla, Kenneth R.

AU - Maldjian, Joseph A

AU - Schmalfuss, Ilona M.

AU - Kuhn, Matthew J.

AU - Bowen, Brian C.

AU - Wippold, Franz J.

AU - Runge, Val M.

AU - Knopp, Michael V.

AU - Kremer, Stephane

AU - Wolansky, Leo J.

AU - Anzalone, Nicoletta

AU - Essig, Marco

AU - Gustafsson, Lars

PY - 2006/8/1

Y1 - 2006/8/1

N2 - Purpose: To prospectively compare gadobenate dimeglumine with gadopentetate dimeglumine (0.1 mmol per kilogram body weight) for enhanced magnetic resonance (MR) imaging of central nervous system (CNS) lesions. Materials and Methods: This study was HIPAA-compliant at U.S. centers and was conducted at all centers according to the Good Clinical Practice standard. Institutional review board and regulatory approval were granted; written informed consent was obtained. Seventy-nine men and 78 women (mean age, 50.5 years ± 14.4 [standard deviation]) were randomized to group A (n = 78) or B (n = 79). Patients underwent two temporally separated 1.5-T MR imaging examinations. In randomized order, gadobenate followed by gadopentetate was administered, in group A; order of administration was reversed in group B. Contrast agent administration (volume, speed of injection), imaging parameters before and after injection, and time between injections and postinjection acquisitions were identical for both examinations. Three blinded neuroradiologists evaluated images by using objective image interpretation criteria for diagnostic information end points (lesion border delineation, definition of disease extent, visualization of internal morphologic features of the lesion, enhancement of the lesion) and quantitative parameters (percentage of lesion enhancement, contrast-to-noise ratio [CNR]). Overall diagnostic preference in terms of lesion conspicuity, detectability, and diagnostic confidence was assessed. Between-group comparisons were performed with Wilcoxon signed rank test. Results: Readers 1, 2, and 3 demonstrated overall preference for gadobenate in 75, 89, and 103 patients, compared with that for gadopentetate in seven, 10, and six patients, respectively (P < .0001). Significant (P < .0001) preference for gadobenate was demonstrated for diagnostic information end points, percentage of lesion enhancement, and CNR. Superiority of gadobenate was significant (P < .001) in patients with intraaxial and extraaxial lesions. Conclusion: Gadobenate compared with gadopentetate at an equivalent dose provides significantly better enhancement and diagnostic information for CNS MR imaging.

AB - Purpose: To prospectively compare gadobenate dimeglumine with gadopentetate dimeglumine (0.1 mmol per kilogram body weight) for enhanced magnetic resonance (MR) imaging of central nervous system (CNS) lesions. Materials and Methods: This study was HIPAA-compliant at U.S. centers and was conducted at all centers according to the Good Clinical Practice standard. Institutional review board and regulatory approval were granted; written informed consent was obtained. Seventy-nine men and 78 women (mean age, 50.5 years ± 14.4 [standard deviation]) were randomized to group A (n = 78) or B (n = 79). Patients underwent two temporally separated 1.5-T MR imaging examinations. In randomized order, gadobenate followed by gadopentetate was administered, in group A; order of administration was reversed in group B. Contrast agent administration (volume, speed of injection), imaging parameters before and after injection, and time between injections and postinjection acquisitions were identical for both examinations. Three blinded neuroradiologists evaluated images by using objective image interpretation criteria for diagnostic information end points (lesion border delineation, definition of disease extent, visualization of internal morphologic features of the lesion, enhancement of the lesion) and quantitative parameters (percentage of lesion enhancement, contrast-to-noise ratio [CNR]). Overall diagnostic preference in terms of lesion conspicuity, detectability, and diagnostic confidence was assessed. Between-group comparisons were performed with Wilcoxon signed rank test. Results: Readers 1, 2, and 3 demonstrated overall preference for gadobenate in 75, 89, and 103 patients, compared with that for gadopentetate in seven, 10, and six patients, respectively (P < .0001). Significant (P < .0001) preference for gadobenate was demonstrated for diagnostic information end points, percentage of lesion enhancement, and CNR. Superiority of gadobenate was significant (P < .001) in patients with intraaxial and extraaxial lesions. Conclusion: Gadobenate compared with gadopentetate at an equivalent dose provides significantly better enhancement and diagnostic information for CNS MR imaging.

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