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The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physician Readers | Experimental | Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir F 18 as part of this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florbetapir F18 | Drug | No Florbetapir F 18 will be administered in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers) | Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure. | Scan acquired 50-60 min post-injection |
| Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers) | Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure. | Scan acquired 50-60 min post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Accuracy (MIMNeuro Software, All Readers) | Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure. | Scan acquired 50-60 min post-injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Philadelphia | Pennsylvania | 19103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Florbetapir PET Scans | No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Florbetapir PET Scans | No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17). |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers) | Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure. | Posted | Mean | Standard Error | Percent Accuracy | Scan acquired 50-60 min post-injection |
|
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No subjects received florbetapir in this study. This study consisted of re-reads of scans previously acquired in other clinical studies (A07, A16, and A17).
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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 | Florbetapir PET Scans | No subjects received florbetapir in this study. This study consisted of re-reads of scans previously acquired in other clinical studies (A07/A16 and A17). |
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No conclusions can be drawn regarding the relative performance of software packages (different readers) or on impact of additional qualitative practice on quantitative interpretation results (Vis Q always after Qualitative).
| 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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| Change in Reliability (MIMNeuro Software) |
Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretation alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics. |
| Scan acquired 50-60 min post-injection |
| Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers) | Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure. | Scan acquired 50-60 min post-injection |
| Change in Reliability (Siemens Syngo.PET Software) | Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretations alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics. | Scan acquired 50-60 min post-injection |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Change |
Change = VisQ - Qualitative |
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|
| Secondary | Change in Total Accuracy (MIMNeuro Software, All Readers) | Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure. | Posted | Mean | Standard Error | Percent Accuracy | Scan acquired 50-60 min post-injection |
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| Secondary | Change in Reliability (MIMNeuro Software) | Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretation alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics. | Posted | Number | 95% Confidence Interval | Fleiss Kappa | Scan acquired 50-60 min post-injection |
|
|
|
|
| Secondary | Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers) | Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure. | Posted | Mean | Standard Error | Percent Accuracy | Scan acquired 50-60 min post-injection |
|
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|
|
| Secondary | Change in Reliability (Siemens Syngo.PET Software) | Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretations alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics. | Posted | Number | 95% Confidence Interval | Fleiss Kappa | Scan acquired 50-60 min post-injection |
|
|
|
|
| Primary | Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers) | Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure. | Posted | Mean | Standard Error | Percent Accuracy | Scan acquired 50-60 min post-injection |
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| 0 |
| 0 |
| 0 |
| 0 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
|
| Non-autopsy cases |
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| Non-autopsy cases |
|