Compare the efficacy of MultiHance and Magnevist
The purpose of this study was to evaluate whether Multihance is superior to Magnevist in terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for the visualization of brain disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
46
0.5 M at a single injection
0.5 M Magnevist at a single dose injection
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States
Global Diagnostic Preference Between the Two Exams
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred. Each patient's image was reviewed by 3 readers.
Time frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Lesion Border Delineation
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred.
Time frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Lesion Contrast Enhancement Between the Two Exams
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred.
Time frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3
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Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Percentage of Lesion Contrast Enhancement (LCE) - Reader 1
Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\]
Time frame: Postdose
Percentage of Contrast Enhancement of the Lesion - Reader 2
Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\]
Time frame: Postdose
Percentage of Contrast Enhancement of the Lesion - Reader 3
Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\]
Time frame: Postdose