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To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]flutemetamol Positron Emission Tomography (PET) Images.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]Flutemetamol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]Flutemetamol | Drug | No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. | Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque. | Post flutemetamol administration |
| Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. | Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque. | Post flutemetamol administration |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-Reader Agreement of PET Images Without Anatomic Images | Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study. | Post Flutemetamol Injection |
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Inclusion Criteria:
Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq.
The subject was classified as one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Sherwin, MD | GE Healthcare | Study Chair |
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This study examined brain PET scans from 276 subjects previously acquired form various GE Healthcare studies (GE-067. The study did not enroll the blinded image Readers.
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| ID | Title | Description |
|---|---|---|
| FG000 | [18F]Flutemetamol | No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to show the PET Image Interpretations among investigators. The study did not enroll the blinded image Readers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | [18F]Flutemetamol | No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to evaluate the effectiveness of an electronic training program for orienting and interpreting Flutemetamol Positive Emission Tomography (PET) Images. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. | Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque. | Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had abnormal Standard of Truth (SoT). | Posted | Number | 95% Confidence Interval | Percentage (True Positive) | Post flutemetamol administration |
|
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No adverse event data collected because no subjects were dosed in this study.
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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 | [18F]Flutemetamol | No adverse event data collected because no subjects were dosed in this study , therefore no subjects were at risk. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Sherwin, M.D. | GE Healthcare | 1-609-514-6820 | paulsherwin@ge.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C581552 | flutemetamol |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Inter-Reader Agreement of PET Images Without Anatomic Images | Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study. | Posted | Number | Number of inter-reader agreements | Post Flutemetamol Injection |
|
|
|
| Primary | Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. | Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque. | Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had normal Standard of Truth (SoT). | Posted | Number | 95% Confidence Interval | Percentage (True Negative) | Post flutemetamol administration |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| Title | Measurements |
|---|
|
| Reader 1 vs Reader 5 |
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| Reader 2 vs Reader 3 |
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| Reader 2 vs Reader 4 |
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| Reader 2 vs Reader 5 |
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| Reader 3 vs Reader 4 |
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| Reader 3 vs Reader 5 |
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| Reader 4 vs Reader 5 |
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| Readers 1,2,3,4,5 |
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| Title | Measurements |
|---|---|
|
| Reader 4 |
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| Reader 5 |
|
| Majority Read |
|