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

Primary Purpose

Alzheimer's Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Florbetapir (18F)
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physician Readers

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Percent Agreement with Expert Panel
Individual reader scan results will be compared to the expert panel's consensus rating for each scan.

Secondary Outcome Measures

Change in inter reader reliability after application of quantitation software
Evaluate the percent change in inter reader reliability after implementation of quantitation analysis.
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.

Full Information

First Posted
January 6, 2014
Last Updated
October 22, 2014
Sponsor
Avid Radiopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02029547
Brief Title
Evaluation of Electronic Florbetapir (18F) Interpretation Training in Japanese Physicians
Official Title
Evaluation of Computer-Based Training to Educate Japanese Physicians in the Methods of Interpreting Florbetapir (18F) PET Scans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Withdrawn
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physician Readers
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Florbetapir (18F)
Other Intervention Name(s)
Florbetapir F 18, florbetapir, Amyvid, 18F-AV-45
Intervention Description
No Florbetapir (18F) will be administered in this study.
Primary Outcome Measure Information:
Title
Inter Rater Reliability
Description
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.
Time Frame
Scan acquired 50-60 minutes post injection
Title
Percent Agreement with Expert Panel
Description
Individual reader scan results will be compared to the expert panel's consensus rating for each scan.
Time Frame
Scan acquired 50-60 minutes post-injection
Secondary Outcome Measure Information:
Title
Change in inter reader reliability after application of quantitation software
Description
Evaluate the percent change in inter reader reliability after implementation of quantitation analysis.
Time Frame
Scan acquired 50-60 minutes post injection
Title
Change in agreement with expert panel
Description
The percent change in individual reader agreement with the expert panel's consensus rating will determined after implementation of quantitation analysis.
Time Frame
Scan acquired 50-60 minutes post-injection

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
100-0005
Country
Japan

12. IPD Sharing Statement

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

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