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Purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadobutrol (Gadovist, BAY86-4875) | Drug | A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scores for visualization parameter: degree of contrast enhancement | Blinded readers evaluate contrast of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale. | Day of gadobutrol injection (Day 0) |
| Scores for visualization parameter: border delineation | Blinded readers evaluate border delineation of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale. | Day of gadobutrol injection (Day 0) |
| Scores for visualization parameter: internal morphology | Blinded readers evaluate internal morphology of at maximum 5 lesions and 4 normal structures in scans taken with and without gadobutrol on a 3-point-scale. | Day of gadobutrol injection (Day 0) |
| Number of detected lesions | Blinded readers determine number of detected lesions in scans with and without gadobutrol. | Day of gadobutrol injection (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of exact match of the MRI diagnosis with the final clinical diagnosis | An exact match is defined as identical diagnosis given by the blinded reader and the independent standard of truth committee. | Day of gadobutrol injection (Day 0) |
| Sensitivity and specificity to detect abnormal/normal brain tissue |
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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 |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | 455-8530 | Japan | |||
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| ID | Term |
|---|---|
| C090600 | gadobutrol |
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Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets. |
| Day of gadobutrol injection (Day 0) |
| Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions | Percentage to correctly detect presence and absence of malignant lesions which are derived from the MR diagnosis of readers when compared with the diagnosis of the independent standard of truth committee. | Day of gadobutrol injection (Day 0) |
| Number of participants with treatment emergent adverse events as a measure of safety and tolerability | 3 days after injection (Day 3) |
| Funabashi |
| Chiba |
| 274-8503 |
| Japan |
| Fukuoka | Fukuoka | 810-0001 | Japan |
| Fukuoka | Fukuoka | 811-0213 | Japan |
| Kitakyushu | Fukuoka | 800-0057 | Japan |
| Fukuyama | Hiroshima | 720-0825 | Japan |
| Kobe | Hyōgo | 650-0047 | Japan |
| Kobe | Hyōgo | 654-0047 | Japan |
| Fujisawa | Kanagawa | 251-8550 | Japan |
| Kawasaki | Kanagawa | 210-0013 | Japan |
| Yokohama | Kanagawa | 226-0025 | Japan |
| Daitō | Osaka | 574-0074 | Japan |
| Kishiwada | Osaka | 596-8522 | Japan |
| Shimonoseki | Yamaguchi | 750-0061 | Japan |
| Ube | Yamaguchi | 755-0151 | Japan |