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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MultiHance | Active Comparator | 0.5 M MultiHance at a single injection |
|
| Magnevist | Active Comparator | 0.5 M Magnevist at a single injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multihance | Drug | 0.5 M at a single injection |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianpaolo Priovano, M.D. | Bracco Diagnostics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bracco Diagnostics, Inc. | Princeton | New Jersey | 08540 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19306364 | Result | Rumboldt Z, Rowley HA, Steinberg F, Maldjian JA, Ruscalleda J, Gustafsson L, Bastianello S. Multicenter, double-blind, randomized, intra-individual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine in MRI of brain tumors at 3 tesla. J Magn Reson Imaging. 2009 Apr;29(4):760-7. doi: 10.1002/jmri.21695. |
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47 patients enrolled (signed informed consent); 46 were randomized and dosed.
A total of 47 patients were recruited from March 2007 through February 2008 at 8 clinical trial sites. from Feb/18/2008 to Feb/22/2008, an off-site assessment of the images was performed by 3 board-certified radiologists who were blinded to which contrast agent was used, any patient's clinical information & any results from other imaging studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | MultiHance, Then Magnevist | 0.1 mmol/kg injection of each product |
| FG001 | Magnevist, Then MultiHance | 0.1 mmol/kg injection of each product |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | MultiHance, Then Magnevist | 0.1 mmol/kg injection of each product |
| BG001 | Magnevist, Then MultiHance | 0.1 mmol/kg injection of each product |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Include all intention-to-treat (ITT) population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis. | Posted | Number | Contrast-enhanced Images | Postdose Images for MultiHance Exam and for Magnevist Exam Compared |
|
Adverse events were monitored from time of signed informed consent, & within 24 hrs prior to administration of contrast agent (1st exam) until 24 hrs after administration of contrast agent. Repeated for 2nd exam.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MultiHance | Adverse events experienced by patients occurred relative to the administration of MultiHance. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gianpaolo Pirovano, MD, Executive Director, Head Corporate Medical Development | Bracco Diagnostics Inc. | 609-514-2226 | gianpaolo.pirovano@diag.bracco.com |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C064572 | gadobenic acid |
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Arm 2 - Magnevist | Drug | 0.5 M Magnevist at a single dose injection |
|
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Reader 2 |
Reader 2 Assessment |
| OG002 | Reader 3 | Reader 3 Assessment |
|
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| Secondary | 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. | Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis. | Posted | Number | Contrast-enhanced Images | Postdose Images for MultiHance Exam and for Magnevist Exam Compared | Contrast-enhanced Images | Contrast-enhanced Images |
|
|
|
|
| Secondary | 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. | Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis. | Posted | Number | Contrast-enhanced Images | Postdose Images for MultiHance Exam and for Magnevist Exam Compared | Contrast-enhanced Images | Contrast-enhanced Images |
|
|
|
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| Secondary | 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. | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis. | Posted | Mean | Standard Deviation | [ratio] | Predose and immediately postdose | Lesions | Lesions |
|
|
|
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| Secondary | 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. | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis. | Posted | Mean | Standard Deviation | [ratio] | Predose and immediately postdose | Lesions | Lesions |
|
|
|
|
| Secondary | 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. | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis. | Posted | Mean | Standard Deviation | [ratio] | Predose and immediately postdose | Lesions | Lesions |
|
|
|
|
| Secondary | 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. | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis. | Posted | Mean | Standard Deviation | [ratio] | Predose and immediately postdose | Lesions | Lesions |
|
|
|
|
| Secondary | 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. | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis. | Posted | Mean | Standard Deviation | [ratio] | Predose and immediately postdose | Lesions | Lesions |
|
|
|
|
| Secondary | 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. | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis. | Posted | Mean | Standard Deviation | [ratio] | Predose and immediately postdose | Lesions | Lesions |
|
|
|
|
| Secondary | 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)] | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis. | Posted | Mean | Standard Deviation | [percent] | Postdose | Lesions | Lesions |
|
|
|
|
| Secondary | 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)] | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis. | Posted | Mean | Standard Deviation | [percent] | Postdose | Lesions | Lesions |
|
|
|
|
| Secondary | 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)] | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis. | Posted | Mean | Standard Deviation | [percent] | Postdose | Lesions | Lesions |
|
|
|
|
| 0 |
| 43 |
| 4 |
| 43 |
| EG001 | Magnevist | Adverse events experienced by patients occurred relative to the administration of Magnevist. | 0 | 44 | 1 | 44 |
| Fatigue | General disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
The results of the study may be presented during scientific symposia or published in a scientific journal only after review by Bracco in accordance with the guidelines set forth in the applicable publication or financial agreement.
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000085 |
| Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
|
| Magnevist Preferred |
|
| 0.001 |
Reader 2 |
| Superiority or Other (legacy) |
| wilcoxon signed-rank test | 0.0002 | Reader 3 | Superiority or Other (legacy) |
|
| Magnevist Preferred |
|
| <0.0001 |
Reader 2 |
| Superiority or Other (legacy) |
| wilcoxon signed-rank test | <0.0001 | Reader 3 | Superiority or Other (legacy) |
| Change from Baseline |
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| Change from Baseline |
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| Change from Baseline |
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| Change from Baseline |
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| Change from Baseline |
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| Change from Baseline |
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