Evaluation of Reader Training Processes
This study is currently recruiting participants.
Verified March 2014 by Avid Radiopharmaceuticals
Information provided by (Responsible Party):
First received: January 30, 2014
Last updated: March 5, 2014
Last verified: March 2014
This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Reader Training Processes by Comparing Clinical Interpretations to Centralized Expert Reads|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Avid Radiopharmaceuticals:
Primary Outcome Measures:
- Agreement between expert panel and clinical practice reads [ Time Frame: Scan acquired 50-60 minutes post injection ] [ Designated as safety issue: No ]Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations will be calculated as a weighted Kappa value across all cases and all clinical practice readers.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Clinical Practice Scans
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.
Drug: florbetapir F 18
No study drug will be administered in this study - scans previously acquired in the course of clinical practice.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02051790
|Contact: Avid Clinical Operationsfirstname.lastname@example.org|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
Sponsors and Collaborators
|Study Director:||Chief Medical Officer||Avid Radiopharmaceuticals|