Evaluation of Web-based Training to Educate Physicians in the Methods of Interpreting Florbetapir-PET Scans

Not Applicable

Completed

• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Neurodegenerative Diseases

• Registration Number: NCT01550549
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

This study will investigate the performance of physician readers trained to read florbetapir-PET scans using electronic media training.

Detailed Description

Avid has previously developed a florbetapir-PET scan binary read methodology and training program, which was successfully applied in studies 18F-AV-45-A08(NCT01565369), 18F-AV-45-A09(NCT01565382) and 18F-AV-45-A16(NCT01447719). In these previous studies, training was conducted in-person. Study 18F-AV-45-PT01 will evaluate an automated version of this training program suitable for web-based distribution. Nuclear medicine physicians will complete the automated training program then read the florbetapir-PET images from 151 subjects with repeat readings of 33 randomly selected images. Readers will rate each case as either positive for significant tracer accumulation in cortical gray matter or negative for significant tracer accumulation in cortical gray matter. The inter-rater reliability, sensitivity and specificity of the readers will be evaluated.

The primary image set for determination of inter-reader agreement is comprised of images from 119 subjects from two previous clinical studies (A07\[NCT00857415\]/A16\[NCT01447719\] and A05\[NCT00702143\]). This included all 59 subjects who came to autopsy in Study A07(NCT00857415) and it's follow-up study, A16(NCT01447719), and a set of 60 cases randomly selected from Study A05(NCT00702143) subjects, including 20 cognitively-normal controls, 20 with mild cognitive impairment) MCI, 20 with AD.

Subsequently, the protocol was amended to include all remaining A05(NCT00702143) MCI patients that were not used in the training program (n=32); 13 of these 32 scans presented for repeat reading (to increase the number of A05 MCI cases with repeated reads to 20). This increased the number of unique cases in the validation dataset to 151 scans with 33 scans repeated yielding a total of 184 scans reviewed by the readers.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• 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: 151

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Inter-rater Reliability	Scan acquired 50-60 min post-injection	Measure of agreement among five readers using a binary read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of Florbetapir-PET to Detect Moderate to Frequent Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)	at autopsy, within 2 years of scan	Calculated as the percent of true positives which are correctly identified
Specificity of Florbetapir-PET to Detect no or Sparse Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)	at autopsy, within 2 years of scan	Calculated as the percent of true negatives which are correctly identified