Evaluation of Electronic Florbetapir (18F) Interpretation Training in Japanese Physicians

Not Applicable

Withdrawn

• Conditions: Alzheimer's Disease
• Interventions: Drug: Florbetapir (18F)

• Registration Number: NCT02029547
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

This study is designed to validate the Japanese electronic florbetapir (18F) interpretation training program intended for post-approval implementation in Japan.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Status Verified: 2014-10
• Study Start: 2014-10
• Last Update Submitted: 2014-10-22
• Last Update Posted: 2014-10-23
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Japanese Society of Nuclear Medicine (JSNM) Positron Emission Tomography (PET) Certified Nuclear Medicine Physician
• Minimal hands-on experience and no formal training in the visual interpretation of florbetapir (18F) brain PET scans
• Minimal hands-on experience and no formal training in the quantitation of florbetapir (18F) brain PET scans

Exclusion Criteria

• Prior hands-on experience or formal training in the visual interpretation and/or quantitation of florbetapir (18F) PET scans

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physician Readers	Florbetapir (18F)	Physician readers will interpret 60 Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to florbetapir (18F) as part of this study.

Primary Outcome Measures

Name	Time	Method
Inter Rater Reliability	Scan acquired 50-60 minutes post injection	Measure of agreement among readers using a binary visual read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information.
Percent Agreement with Expert Panel	Scan acquired 50-60 minutes post-injection	Individual reader scan results will be compared to the expert panel's consensus rating for each scan.

Secondary Outcome Measures

Name	Time	Method
Change in agreement with expert panel	Scan acquired 50-60 minutes post-injection	The percent change in individual reader agreement with the expert panel's consensus rating will determined after implementation of quantitation analysis.
Change in inter reader reliability after application of quantitation software	Scan acquired 50-60 minutes post injection	Evaluate the percent change in inter reader reliability after implementation of quantitation analysis.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan