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This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MULTIHANCE | Active Comparator | gadobenate dimeglumine |
|
| GADOVIST | Active Comparator | gadobutrol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MULTIHANCE: | Drug | MULTIHANCE ® 0.5 M,0.1 mmol/kg |
| |
| GADOVIST |
| Measure | Description | Time Frame |
|---|---|---|
| To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets). | Day 1 and Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianpaolo Pirovano, MD | Bracco Diagnostics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences Corporation | Hamilton | Ontario | Canada |
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| ID | Term |
|---|---|
| C064572 | gadobenic acid |
| C090600 | gadobutrol |
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| Drug |
GADOVIST ® 1.0 M,0.1 mmol/kg |
|