Abstract
Purpose To investigate the efficacy and safety of three doses of gadobutrol and determine the minimum effective dose for contrast-enhanced MRI of the central nervous system (CNS). Materials and Methods This was a Phase II, multicenter, double-blind, parallel-group controlled study in subjects referred for contrast-enhanced MRI of the CNS. Subjects were randomized to receive gadobutrol 0.03, 0.1, or 0.3 mmol/kg body weight, and underwent unenhanced, gadobutrol-enhanced, and comparator-enhanced MRI scans. Three blinded readers assessed the images. Primary efficacy variables were number of lesions detected, border delineation, contrast enhancement, and internal morphology. Results Of the 229 randomized subjects, 173 were evaluated for efficacy. Clinically meaningful improvements in lesion border delineation, contrast enhancement, and internal morphology were observed for 0.1 mmol/kg gadobutrol. Pair-wise comparisons of a composite score of the four primary variables showed the 0.1 mmol/kg dose to be statistically superior to the 0.03 mmol/kg dose (P = 0.003). The 0.3 mmol/kg dose showed no statistically significant difference with the 0.1 mmol/kg dose. Twenty-two (9.8%) subjects reported at least one treatment-emergent adverse event (TEAE). No TEAE was reported at an incidence >3.5%. Conclusion The 0.1 mmol/kg dose of gadobutrol was effective and well tolerated for contrast-enhanced MRI of the CNS.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 410-418 |
| Number of pages | 9 |
| Journal | Journal of Magnetic Resonance Imaging |
| Volume | 39 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 2014 |
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Keywords
- central nervous system
- contrast-enhanced magnetic resonance imaging
- gadobutrol
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
Cite this
Gadobutrol in the central nervous system at three doses : Results from a phase II, randomized, multicenter trial. / Breuer, Josy; Gutierrez, Juan; Latchaw, Richard E; Lehr, Robert; Sorensen, A. Gregory.
In: Journal of Magnetic Resonance Imaging, Vol. 39, No. 2, 02.2014, p. 410-418.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Gadobutrol in the central nervous system at three doses
T2 - Results from a phase II, randomized, multicenter trial
AU - Breuer, Josy
AU - Gutierrez, Juan
AU - Latchaw, Richard E
AU - Lehr, Robert
AU - Sorensen, A. Gregory
PY - 2014/2
Y1 - 2014/2
N2 - Purpose To investigate the efficacy and safety of three doses of gadobutrol and determine the minimum effective dose for contrast-enhanced MRI of the central nervous system (CNS). Materials and Methods This was a Phase II, multicenter, double-blind, parallel-group controlled study in subjects referred for contrast-enhanced MRI of the CNS. Subjects were randomized to receive gadobutrol 0.03, 0.1, or 0.3 mmol/kg body weight, and underwent unenhanced, gadobutrol-enhanced, and comparator-enhanced MRI scans. Three blinded readers assessed the images. Primary efficacy variables were number of lesions detected, border delineation, contrast enhancement, and internal morphology. Results Of the 229 randomized subjects, 173 were evaluated for efficacy. Clinically meaningful improvements in lesion border delineation, contrast enhancement, and internal morphology were observed for 0.1 mmol/kg gadobutrol. Pair-wise comparisons of a composite score of the four primary variables showed the 0.1 mmol/kg dose to be statistically superior to the 0.03 mmol/kg dose (P = 0.003). The 0.3 mmol/kg dose showed no statistically significant difference with the 0.1 mmol/kg dose. Twenty-two (9.8%) subjects reported at least one treatment-emergent adverse event (TEAE). No TEAE was reported at an incidence >3.5%. Conclusion The 0.1 mmol/kg dose of gadobutrol was effective and well tolerated for contrast-enhanced MRI of the CNS.
AB - Purpose To investigate the efficacy and safety of three doses of gadobutrol and determine the minimum effective dose for contrast-enhanced MRI of the central nervous system (CNS). Materials and Methods This was a Phase II, multicenter, double-blind, parallel-group controlled study in subjects referred for contrast-enhanced MRI of the CNS. Subjects were randomized to receive gadobutrol 0.03, 0.1, or 0.3 mmol/kg body weight, and underwent unenhanced, gadobutrol-enhanced, and comparator-enhanced MRI scans. Three blinded readers assessed the images. Primary efficacy variables were number of lesions detected, border delineation, contrast enhancement, and internal morphology. Results Of the 229 randomized subjects, 173 were evaluated for efficacy. Clinically meaningful improvements in lesion border delineation, contrast enhancement, and internal morphology were observed for 0.1 mmol/kg gadobutrol. Pair-wise comparisons of a composite score of the four primary variables showed the 0.1 mmol/kg dose to be statistically superior to the 0.03 mmol/kg dose (P = 0.003). The 0.3 mmol/kg dose showed no statistically significant difference with the 0.1 mmol/kg dose. Twenty-two (9.8%) subjects reported at least one treatment-emergent adverse event (TEAE). No TEAE was reported at an incidence >3.5%. Conclusion The 0.1 mmol/kg dose of gadobutrol was effective and well tolerated for contrast-enhanced MRI of the CNS.
KW - central nervous system
KW - contrast-enhanced magnetic resonance imaging
KW - gadobutrol
UR - http://www.scopus.com/inward/record.url?scp=84892829618&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84892829618&partnerID=8YFLogxK
U2 - 10.1002/jmri.24180
DO - 10.1002/jmri.24180
M3 - Article
C2 - 23681501
AN - SCOPUS:84892829618
VL - 39
SP - 410
EP - 418
JO - Journal of Magnetic Resonance Imaging
JF - Journal of Magnetic Resonance Imaging
SN - 1053-1807
IS - 2
ER -