The Feasibility of Florbetapir Quantitation in Europe

Phase 4

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Florbetapir (18F)

• Registration Number: NCT02107599
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2015-05-29
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-17
• Last Update Submitted: 2015-06-17
• Results First Posted: 2015-07-09
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

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

Inclusion Criteria

• Readers have undergone Amyvid reader training
• Readers have not more than 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 (18F)	Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir(18F) as part of this study.

Primary Outcome Measures

Name	Time	Method
Change in Reader Accuracy After Application of Quantitation Software	Scan acquired 50-60 minutes post injection	Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values \>0 indicate an improvement in scan interpretation accuracy and values \<0 indicate a decline in scan interpretation accuracy after application of quantitation software.; NRI = \[P(up,event)-P(down,event)\]-\[P(up,nonevent)-P(down,nonevent)\] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative; Only the 46 scans with autopsy from A16 are used for this outcome measure.

Secondary Outcome Measures

Name	Time	Method
Change in Scan Interpretation Reliability After Application of Quantitation Software	Scan acquired 50-60 minutes post injection	Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values \>0 indicate an improvement in scan interpretation accuracy and values \<0 indicate a decline in scan interpretation accuracy after application of quantitation software.; NRI = \[P(up,event)-P(down,event)\]-\[P(up,nonevent)-P(down,nonevent)\] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative; Only the 46 scans with autopsy from A16 are used for this outcome measure.

Trial Locations

Locations (1)

Research Site; 🇳🇱 Leiden, Netherlands