- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02029547
Evaluation of Electronic Florbetapir (18F) Interpretation Training in Japanese Physicians
October 22, 2014 updated by: Avid Radiopharmaceuticals
Evaluation of Computer-Based Training to Educate Japanese Physicians in the Methods of Interpreting Florbetapir (18F) PET Scans
This study is designed to validate the Japanese electronic florbetapir (18F) interpretation training program intended for post-approval implementation in Japan.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan, 100-0005
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physician Readers
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.
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No Florbetapir (18F) will be administered in this study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inter Rater Reliability
Time Frame: Scan acquired 50-60 minutes post injection
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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.
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Scan acquired 50-60 minutes post injection
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Percent Agreement with Expert Panel
Time Frame: Scan acquired 50-60 minutes post-injection
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Individual reader scan results will be compared to the expert panel's consensus rating for each scan.
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Scan acquired 50-60 minutes post-injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in inter reader reliability after application of quantitation software
Time Frame: Scan acquired 50-60 minutes post injection
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Evaluate the percent change in inter reader reliability after implementation of quantitation analysis.
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Scan acquired 50-60 minutes post injection
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Change in agreement with expert panel
Time Frame: Scan acquired 50-60 minutes post-injection
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The percent change in individual reader agreement with the expert panel's consensus rating will determined after implementation of quantitation analysis.
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Scan acquired 50-60 minutes post-injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
May 1, 2015
Study Completion (Anticipated)
May 1, 2015
Study Registration Dates
First Submitted
January 6, 2014
First Submitted That Met QC Criteria
January 6, 2014
First Posted (Estimate)
January 8, 2014
Study Record Updates
Last Update Posted (Estimate)
October 23, 2014
Last Update Submitted That Met QC Criteria
October 22, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18F-AV-45-JPT01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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