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

Alzheimer's Disease Clinical Trial

Official title:

Evaluation of Computer-Based Training to Educate Japanese Physicians in the Methods of Interpreting Florbetapir (18F) PET Scans

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02029547
• Other study ID #: 18F-AV-45-JPT01
• Status: Withdrawn
• Phase: N/A
• First received: January 6, 2014
• Last updated: October 22, 2014
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2014
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Florbetapir (18F)
No Florbetapir (18F) will be administered in this study.

Locations

Country	Name	City	State
Japan	Research Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter Rater Reliability	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.	Scan acquired 50-60 minutes post injection	No
Primary	Percent Agreement with Expert Panel	Individual reader scan results will be compared to the expert panel's consensus rating for each scan.	Scan acquired 50-60 minutes post-injection	No
Secondary	Change in inter reader reliability after application of quantitation software	Evaluate the percent change in inter reader reliability after implementation of quantitation analysis.	Scan acquired 50-60 minutes post injection	No
Secondary	Change in agreement with expert panel	The percent change in individual reader agreement with the expert panel's consensus rating will determined after implementation of quantitation analysis.	Scan acquired 50-60 minutes post-injection	No