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To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MultiHance contrast agent | Experimental | MultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg) |
|
| Magnevist | Active Comparator | Magnevist administered at a dose of 0.2 mmol/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadobenate Dimeglumine | Drug | 0.1 mmol/kg, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Preference | Comparison of a single dose of MultiHance versus the double dose of Magnevist currently used for MR Angiography of the carotid, renal/abdominal/ and peripheral arteries in terms of global diagnostic perference | Immediately post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety comparison of two diagnostic agents | to compare the safety of the two investigational products in patients undergoing CE-MRA of the carotid, renal/abdominal and peripheral arteries | UP to 24 hours post dose of each contrast agent |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiology Department Zhongshan Hospital, Fudan University | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23042922 | Derived | Li Y, Li X, Li D, Lu J, Xing X, Yan F, Li Y, Wang X, Iezzi R, De Cobelli F. Multicenter, intraindividual comparison of single-dose gadobenate dimeglumine and double-dose gadopentetate dimeglumine for MR angiography of the supra-aortic arteries (the Supra-Aortic VALUE study). AJNR Am J Neuroradiol. 2013 Apr;34(4):847-54. doi: 10.3174/ajnr.A3298. Epub 2012 Oct 4. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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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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| Gadopentetate Dimeglumine | Drug | Double dose of 0.2 mmol/kg |
|
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D000085 |
| Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |