The Feasibility of Florbetapir Quantitation

Study Overview
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Brief Summary
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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.

Official Title
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The Feasibility and Reliability of Utilizing Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Qualitative Interpretation of Amyvid Brain Scans

Conditions
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Alzheimers Disease

Intervention / Treatment
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* Drug: Florbetapir F18


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Readers have undergone Amyvid reader training Readers have minimal experience with quantitation of amyloid PET scans Exclusion Criteria: Readers have previously been trained to quantitate amyloid PET scans
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physician Readers<br>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. | Drug: Florbetapir F18<br>* No Florbetapir F 18 will be administered in this study.<br>* Other names: florbetapir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |