Evaluation of Physician Training Methods to Read Florbetapir-PET Scans

Not Applicable

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT01565369
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

The purpose of this study is re-read of brain amyloid positron emission tomography (PET) scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had an autopsy to reveal the subject's true amyloid status.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Results First Submitted: 2012-04-06
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-03
• Last Update Submitted: 2012-05-03
• Results First Posted: 2012-06-07
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque	50-60 min after injection	Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers.
Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque	50-60 min after injection	Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers.

Secondary Outcome Measures

Name	Time	Method
Inter-reader Agreement	50-60 min after injection	Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers