Multihance at 3 Tesla (3T) in Brain Tumors

Study Overview
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Brief Summary
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Compare the efficacy of MultiHance and Magnevist

Detailed Description
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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.

Official Title
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A Phase IV Double-blind Multicenter Randomized Crossover Study to Compare 0.10 mmol/kg of Multihance With 0.10 mmol.kg of Magnevist in Magnetic Resonance Imaging(MRI) of the Brain at 3T

Conditions
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Brain Tumor

Intervention / Treatment
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* Drug: Multihance
* Drug: Arm 2 - Magnevist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Was 18 years or older Provided written informed consent Scheduled for MRI Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days Exclusion Criteria: Pregnant or lactating females Allergy to one or more of the ingredients in the products or hypersensitivity to any metals Congestive heart failure, class IV Previous stroke in the past year Received another contrast agent within 24 hours pre and post each exam Investigational product Contraindications to MRI Severe claustrophobia Surgery with 3 weeks prior Steroid therapy or radiosurgery between two exams

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MultiHance<br>0.5 M MultiHance at a single injection | Drug: Multihance<br>* 0.5 M at a single injection<br>* Other names: gadobenate dimeglumine;|
| Active Comparator: Magnevist<br>0.5 M Magnevist at a single injection | Drug: Arm 2 - Magnevist<br>* 0.5 M Magnevist at a single dose injection<br>* Other names: gadopentetate dimeglumine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Postdose Images for MultiHance Exam and for Magnevist Exam Compared | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Predose and immediately postdose | 
| Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3 | Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed. | 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. | 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. | 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. | 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)] | 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)] | 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)] | Postdose |