Back to resultsEvaluation of Reader Training Processes
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
florbetapir F 18
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Scan obtained for clinical reasons
Exclusion Criteria:
- None
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Clinical Practice Scans
Arm Description
Approximately 250 florbetapir F 18 scans and final scan reports interpreted in a clinical setting will be collected from physicians across the country. These results will then be compared to expert panel interpretations for the same scans.
Outcomes
Primary Outcome Measures
Agreement Between Expert Panel and Clinical Practice Reads
Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.
Secondary Outcome Measures
Full Information
NCT ID
NCT02051790
First Posted
January 30, 2014
Last Updated
August 27, 2015
Sponsor
Avid Radiopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02051790
Brief Title
Evaluation of Reader Training Processes
Official Title
Evaluation of Reader Training Processes by Comparing Clinical Interpretations to Centralized Expert Reads
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
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 evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.
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
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Practice Scans
Arm Type
Experimental
Arm Description
Approximately 250 florbetapir F 18 scans and final scan reports interpreted in a clinical setting will be collected from physicians across the country. These results will then be compared to expert panel interpretations for the same scans.
Intervention Type
Drug
Intervention Name(s)
florbetapir F 18
Other Intervention Name(s)
18F-AV-45, Amyvid, florbetapir
Intervention Description
No study drug will be administered in this study - scans previously acquired in the course of clinical practice.
Primary Outcome Measure Information:
Title
Agreement Between Expert Panel and Clinical Practice Reads
Description
Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.
Time Frame
Scan acquired 50-60 minutes post injection
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Scan obtained for clinical reasons
Exclusion Criteria:
- None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Evaluation of Reader Training Processes
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