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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000981-22 | EudraCT Number |
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PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-18 FEDAA1106 (BAY85-8101) | Drug | MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standard quantification variables derived from 3D PET imaging and brain modeling. | Day of study tracer administration | |
| Visual analysis/description of the uptake and description of brain PET scans. | Day of study tracer administration |
| Measure | Description | Time Frame |
|---|---|---|
| Standard Safety Parameter: Adverse Event Collection | maximum time from Screening to Follow-up are 37days | |
| Standard Safety Parameter: Electrocardiogram | maximum time from Screening to Follow-up are 37days |
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Inclusion Criteria:
Healthy volunteers for brain imaging:
Exclusion Criteria:
Exclusion criteria for all healthy volunteers and patients:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heidelberg | Victoria | 3084 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23618062 | Derived | Takano A, Piehl F, Hillert J, Varrone A, Nag S, Gulyas B, Stenkrona P, Villemagne VL, Rowe CC, Macdonell R, Tawil NA, Kucinski T, Zimmermann T, Schultze-Mosgau M, Thiele A, Hoffmann A, Halldin C. In vivo TSPO imaging in patients with multiple sclerosis: a brain PET study with [18F]FEDAA1106. EJNMMI Res. 2013 Apr 24;3(1):30. doi: 10.1186/2191-219X-3-30. |
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| F-18 FEDAA1106 (BAY85-8101) | Drug | Healthy controls: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET |
|
| Standard Safety Parameter: Safety laboratory | maximum time from Screening to Follow-up are 37days |
| Standard Safety Parameter: Vital signs | maximum time from Screening to Follow-up are 37days |
| Stockholm |
| 171 76 |
| Sweden |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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