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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000962-21 | EudraCT Number |
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This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-18 (BAY85-8050) | Drug | Cancer patients, injection of BAY 85-8050, PET/CT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual assessment of lesions | Within up to 2 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs) | Within up to 2 hours after treatment | |
| Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total protein |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| München | Bavaria | 81675 | Germany |
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| F-18 (BAY85-8050) |
| Drug |
Healthy volunteers, injection of BAY 85-8050, whole body PET/CT for determination of effective dose, kinetics of BAY 85-8050 in blood |
|
| At least 2 times within 8 days after treatment |
| Electrocardiogram (ECG) | at least 2 times within 8 days after treatment |
| Vital signs: Heart rate, blood pressure | at least 2 times within 8 days after treatment |
| Adverse events collection | continuously for at least 8 days after treatment |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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