The Feasibility of Florbetapir Quantitation
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
- Change in reader accuracy after application of quantitation software [ Time Frame: Scan acquired 50-60 min post injection ] [ Designated as safety issue: No ]Evaluate whether the use of quantitation software improves the total accuracy of florbetapir F 18 scan interpretation. Total accuracy is defined as the number of scans correctly interpreted (vs. a truth standard) divided by the total number of scans read.
- Change in scan interpretation reliability after application of quantitation software [ Time Frame: Scan acquired 50-60 min post injection ] [ Designated as safety issue: No ]Evaluate whether the use of quantitation software improves the reliability of florbetapir F 18 scan interpretation. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Physician Readers
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
No Florbetapir F 18 will be administered in this study.
|Contact: Avid Clinical Operationsemail@example.com|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19103|
|Study Director:||Chief Medical Officer||Avid Radiopharmaceuticals, Inc.|