Multihance at 3 Tesla (3T) in Brain Tumors

Phase 4

Completed

• Conditions: Brain Tumor
• Interventions: Drug: Arm 2 - Magnevist; Drug: Multihance

• Registration Number: NCT00395863
• Lead Sponsor: Bracco Diagnostics, Inc

Brief Summary

Compare the efficacy of MultiHance and Magnevist

Detailed Description

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 Timeline

• Study First Submitted: 2006-09-12
• Study Start: 2006-11
• Study First Submitted QC: 2006-11-03
• Study First Posted: 2006-11-06
• Primary Completion: 2008-02
• Study Completion: 2008-03
• Results First Submitted: 2009-03-30
• Results First Submitted QC: 2009-06-08
• Results First Posted: 2009-07-31
• Status Verified: 2015-03
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Magnevist	Arm 2 - Magnevist	0.5 M Magnevist at a single injection
MultiHance	Multihance	0.5 M MultiHance at a single injection

Primary Outcome Measures

Name	Time	Method
Global Diagnostic Preference Between the Two Exams	Postdose Images for MultiHance Exam and for Magnevist Exam Compared	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.

Secondary Outcome Measures

Name	Time	Method
Lesion Contrast Enhancement Between the Two Exams	Postdose Images for MultiHance Exam and for Magnevist Exam Compared	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.
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1	Predose and immediately postdose	Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2	Predose and immediately postdose	Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1	Predose and immediately postdose	Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3	Predose and immediately postdose	Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3	Predose and immediately postdose	Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Lesion Border Delineation	Postdose Images for MultiHance Exam and for Magnevist Exam Compared	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.
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2	Predose and immediately postdose	Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Percentage of Lesion Contrast Enhancement (LCE) - Reader 1	Postdose	Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\]
Percentage of Contrast Enhancement of the Lesion - Reader 2	Postdose	Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\]
Percentage of Contrast Enhancement of the Lesion - Reader 3	Postdose	Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\]

Trial Locations

Locations (1)

Bracco Diagnostics, Inc.; 🇺🇸 Princeton, New Jersey, United States