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

Status

Withdrawn

Conditions

Intervention / Treatment

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

      • Tokyo, Japan, 100-0005
        • Research Site

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.
No Florbetapir (18F) will be administered in this study.
Other Names:
  • Amyvid
  • 18F-AV-45
  • florbetapir
  • Florbetapir F 18

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
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
Time Frame: Scan acquired 50-60 minutes post-injection
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 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
Evaluate the percent change in inter reader reliability after implementation of quantitation analysis.
Scan acquired 50-60 minutes post injection
Change in agreement with expert panel
Time Frame: 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.
Scan acquired 50-60 minutes post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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