The Feasibility of Florbetapir Quantitation in Europe

Alzheimer's Disease Clinical Trial

Official title:

A Study to Evaluate the Improvement in Reader Accuracy When Using a Read Method That Incorporates Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Visual Interpretation of Amyvid Brain Scans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107599
• Other study ID #: 18F-AV-45-QP02
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2014
• Last updated: June 17, 2015
• Start date: March 2014
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Florbetapir (18F)
No Florbetapir (18F) will be administered in this study.

Locations

Country	Name	City	State
Netherlands	Research Site	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Reader Accuracy After Application of Quantitation Software	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.	Scan acquired 50-60 minutes post injection	No
Secondary	Change in Scan Interpretation Reliability After Application of Quantitation Software	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.	Scan acquired 50-60 minutes post injection	No