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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02029547

Enrollment

Registered

2014-01-08

Start date

2014-10-31

Completion date

2015-05-31

Last updated

2014-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

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

Interventions

DRUGFlorbetapir (18F)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026