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| Name | Class |
|---|---|
| Covance | INDUSTRY |
| H2O Clinical LLC | INDUSTRY |
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Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The PET brain images previously obtained in Study GE-067-007 will be interpreted visually in randomized by 5 independent readers who are blinded to all other subject information, and the images will be classified as abnormal (positive for abnormal neuritic plaque density) or normal (negative for abnormal neuritic plaque density). The numbers of images in each category will be used to calculate sensitivity and specificity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flutemetamol (18F) | There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Number of Abnormal Blinded Visual PET Image Interpretations. | Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program. | Brain images will be assessed up to 1 year post subject's death. |
| Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans | Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program. | Brain images will be assessed up to 1 year post subject's death. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Blinded Visual PET Image Interpretations | Specificity of blinded visual image interpretations according to neuropathological criteria. | Brain images will be assessed up to 1 year post subject's death. |
| Specificity Percentage of Blinded Visual PET Image Interpretations |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE067-007.
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| Name | Affiliation | Role |
|---|---|---|
| Paul Sherwin, M.D. | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38048354 | Derived | Kim SJ, Jang H, Yoo H, Na DL, Ham H, Kim HJ, Kim JP, Farrar G, Moon SH, Seo SW. Clinical and Pathological Validation of CT-Based Regional Harmonization Methods of Amyloid PET. Clin Nucl Med. 2024 Jan 1;49(1):1-8. doi: 10.1097/RLU.0000000000004937. Epub 2023 Nov 29. | |
| 37777806 | Derived | Tome SO, Tsaka G, Ronisz A, Ospitalieri S, Gawor K, Gomes LA, Otto M, von Arnim CAF, Van Damme P, Van Den Bosch L, Ghebremedhin E, Laureyssen C, Sleegers K, Vandenberghe R, Rousseau F, Schymkowitz J, Thal DR. TDP-43 pathology is associated with increased tau burdens and seeding. Mol Neurodegener. 2023 Sep 30;18(1):71. doi: 10.1186/s13024-023-00653-0. |
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This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flutemetamol (18F) | There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
This study is to assess the images taken previously from another study, GE-067-007. No drug was administered.
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| ID | Title | Description |
|---|---|---|
| BG000 | Flutemetamol (18F) | There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Number of Abnormal Blinded Visual PET Image Interpretations. | Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program. | There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers. | Posted | Number | Number of Blinded Image Interpretations | Brain images will be assessed up to 1 year post subject's death. |
|
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Adverse events were not assessed nor collected in this study. In addition, no drug was administered. Therefore, this study had no adverse events. Subjects were previously dosed in Study GE-067-007.
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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 | Flutemetamol (18F) | This study was to assess the PET images only. There was no drug administered in this study. |
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The Clinical Trials NCT number is 01165554 for GE Healthcare study, GE-067-007.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Sherwin, M.D. | GE Healthcare | 1-609-514-6489 | Paul.Sherwin@ge.com |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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Brain specimen retained. Subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE067-007.
Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain. |
| Brain images will be assessed up to 1 year post subject's death. |
| 31727169 | Derived | Thal DR, Ronisz A, Tousseyn T, Rijal Upadhaya A, Balakrishnan K, Vandenberghe R, Vandenbulcke M, von Arnim CAF, Otto M, Beach TG, Lilja J, Heurling K, Chakrabarty A, Ismail A, Buckley C, Smith APL, Kumar S, Farrar G, Walter J. Different aspects of Alzheimer's disease-related amyloid beta-peptide pathology and their relationship to amyloid positron emission tomography imaging and dementia. Acta Neuropathol Commun. 2019 Nov 14;7(1):178. doi: 10.1186/s40478-019-0837-9. |
| 30123935 | Derived | Thal DR, Beach TG, Zanette M, Lilja J, Heurling K, Chakrabarty A, Ismail A, Farrar G, Buckley C, Smith APL. Estimation of amyloid distribution by [18F]flutemetamol PET predicts the neuropathological phase of amyloid beta-protein deposition. Acta Neuropathol. 2018 Oct;136(4):557-567. doi: 10.1007/s00401-018-1897-9. Epub 2018 Aug 19. |
| 27955679 | Derived | Ikonomovic MD, Buckley CJ, Heurling K, Sherwin P, Jones PA, Zanette M, Mathis CA, Klunk WE, Chakrabarty A, Ironside J, Ismail A, Smith C, Thal DR, Beach TG, Farrar G, Smith AP. Post-mortem histopathology underlying beta-amyloid PET imaging following flutemetamol F 18 injection. Acta Neuropathol Commun. 2016 Dec 12;4(1):130. doi: 10.1186/s40478-016-0399-z. |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Blinded Visual PET Image Interpretations | Specificity of blinded visual image interpretations according to neuropathological criteria. | There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers. | Posted | Number | Number of Blinded Image Intrepretations | Brain images will be assessed up to 1 year post subject's death. |
|
|
|
| Primary | Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans | Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program. | There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers. | Posted | Number | Percent of Sensitivity | Brain images will be assessed up to 1 year post subject's death. |
|
|
|
| Secondary | Specificity Percentage of Blinded Visual PET Image Interpretations | Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain. | There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers. | Posted | Number | Percentage of Specificity | Brain images will be assessed up to 1 year post subject's death. |
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| Title | Measurements |
|---|---|
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| Reader 4-Blinded Visual-Normal Interpretation |
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| Reader 5-Blinded Visual-Normal Interpretation |
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| Majority Read-Normal |
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| Reader 4-Blinded Visual--Abnormal Interpretation |
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| Reader 5-Blinded Visual--Abnormal Interpretation |
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| Majority Read-Abnormal |
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| Title | Measurements |
|---|---|
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| Reader 4-Blinded Visual-Normal Interpretation |
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| Reader 5-Blinded Visual-Normal Interpretation |
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| Majority Read-Normal |
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