Evaluation of Reader Training Processes

Phase 4

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: florbetapir F 18

• Registration Number: NCT02051790
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Study Start: 2014-03
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-08
• Results First Submitted: 2015-08-03
• Results First Submitted QC: 2015-08-27
• Last Update Submitted: 2015-08-27
• Results First Posted: 2015-09-28
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

• Scan obtained for clinical reasons

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical Practice Scans	florbetapir F 18	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.

Primary Outcome Measures

Name	Time	Method
Agreement Between Expert Panel and Clinical Practice Reads	Scan acquired 50-60 minutes post injection	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States