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| ID | Type | Description | Link |
|---|---|---|---|
| 305624 |
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To verify the number of metastatic brain tumors detected in contrast-enhanced MRI, which is the primary variable, increases after an additional dose of Magnevist (SH L 451A) comparing images after an initial dose (0.1 mmol/kg) with those after an additional dose (0.1 mmol/kg, a total dose of 0.2 mmol/kg) intra-individually in patients with metastatic brain tumors. Safety was also to be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnevist (SH L 451A) | Drug | Magnevist at a dose of 0.1 mmol/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic ability | MRI image in blinded read |
| Measure | Description | Time Frame |
|---|---|---|
| Visibility | MRI image in blinded read | |
| Diagnostic confidence | MRI image in blinded read |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yokohama | Kanagawa | 222-0036 | Japan | |||
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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 |
|---|---|
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Magnevist (SH L 451A) |
| Drug |
Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later. |
|
| Osaka |
| Osaka |
| 530-8480 |
| Japan |
| Osaka | Osaka | 537-8511 | Japan |
| Hamamatsu | Shizuoka | 430-8558 | Japan |
| Bunkyo-ku | Tokyo | 113-8677 | Japan |
| Ōta-ku | Tokyo | 145-0065 | Japan |
| Shinagawa-ku | Tokyo | 141-8625 | Japan |
| Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Nakakoma-gun | Yamanashi | 409-3898 | Japan |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000085 |
| Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |