The Feasibility of Florbetapir Quantitation

Phase 4

Completed

• Conditions: Alzheimers Disease
• Interventions: Drug: Florbetapir F18

• Registration Number: NCT01946243
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-19
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-04-27
• Results First Submitted QC: 2015-05-12
• Status Verified: 2015-06
• Results First Posted: 2015-06-01
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Readers have undergone Amyvid reader training
• Readers have minimal experience with quantitation of amyloid PET scans

Exclusion Criteria

• Readers have previously been trained to quantitate amyloid PET scans

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physician Readers	Florbetapir F18	Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir F 18 as part of this study.

Primary Outcome Measures

Name	Time	Method
Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)	Scan acquired 50-60 min post-injection	Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)	Scan acquired 50-60 min post-injection	Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.

Secondary Outcome Measures

Name	Time	Method
Change in Total Accuracy (MIMNeuro Software, All Readers)	Scan acquired 50-60 min post-injection	Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
Change in Reliability (MIMNeuro Software)	Scan acquired 50-60 min post-injection	Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretation alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.
Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)	Scan acquired 50-60 min post-injection	Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
Change in Reliability (Siemens Syngo.PET Software)	Scan acquired 50-60 min post-injection	Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretations alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States