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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study is designed to validate the Japanese electronic florbetapir (18F) interpretation training program intended for post-approval implementation in Japan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2014
CompletedFirst Posted
Study publicly available on registry
January 8, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedOctober 23, 2014
October 1, 2014
7 months
January 6, 2014
October 22, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (2)
Change in inter reader reliability after application of quantitation software
Scan acquired 50-60 minutes post injection
Change in agreement with expert panel
Scan acquired 50-60 minutes post-injection
Study Arms (1)
Physician Readers
EXPERIMENTALPhysician 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.
Interventions
No Florbetapir (18F) will be administered in this study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior hands-on experience or formal training in the visual interpretation and/or quantitation of florbetapir (18F) PET scans
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Site
Tokyo, 100-0005, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2014
First Posted
January 8, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
October 23, 2014
Record last verified: 2014-10