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[18F]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.
Diagnostic validity of [18F]Florbetaben PET for detecting amyloidosis will be assessed in subjects with multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]Florbetaben PET/CT imaging | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]Florbetaben | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| sensitivity and specificity per patient analysis | Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis | Up to 6 months after [18F]Florbetaben PET/CT scanning |
| Measure | Description | Time Frame |
|---|---|---|
| sensitivity and specificity per organ analysis | Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of affected organs with clinical, laboratory, radiological, or histopathological evidence of amyloidosis | Up to 6 months after [18F]Florbetaben PET/CT scanning |
| Correlation with severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Cheol Jo, PhD | Ulsan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulsan University Hospital | Ulsan | South Korea |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C527756 | 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene |
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|
Correlation of [18F]Florbetaben activity with clinical/radiological/histopathological indices of amyloidosis severity |
| Up to 6 months after [18F]Florbetaben PET/CT scanning |
| Adverse events | Adverse events will be monitored. | Up to 28 days after [18F]Florbetaben PET/CT scanning |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |