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This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Practice Scans | Experimental | Approximately 250 florbetapir F 18 scans and final scan reports interpreted in a clinical setting will be collected from physicians across the country. These results will then be compared to expert panel interpretations for the same scans. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | No study drug will be administered in this study - scans previously acquired in the course of clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between Expert Panel and Clinical Practice Reads | Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers. | Scan acquired 50-60 minutes post injection |
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Inclusion Criteria:
- Scan obtained for clinical reasons
Exclusion Criteria:
- None
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinical Practice Scans | 241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans. florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinical Practice Scans | 241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans. florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age was not collected in this study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Agreement Between Expert Panel and Clinical Practice Reads | Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers. | Posted | Number | 95% Confidence Interval | Weighted Kappa statistic | Scan acquired 50-60 minutes post injection |
|
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No study drug was administered in this study - scans previously acquired in the course of clinical practice, therefore no adverse event information was collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinical Practice Scans | 241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans. florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | 215-298-0700 | clinicaloperations@avidrp.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C545186 | florbetapir |
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| Number |
| scans |
|
| Sex/Gender, Customized | Gender was not collected in this study. | Number | scans |
|
| Region of Enrollment | All scans were collected from imaging centers in the US. | Number | scans |
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| Units | Counts |
|---|
| Participants |
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| 0 |
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| 0 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |