The Feasibility of Florbetapir Quantitation

Alzheimers Disease Clinical Trial

Official title:

The Feasibility and Reliability of Utilizing Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Qualitative Interpretation of Amyvid Brain Scans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946243
• Other study ID #: 18F-AV-45-QP01
• Status: Completed
• Phase: Phase 4
• First received: September 17, 2013
• Last updated: June 1, 2015
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

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

Eligibility

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

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimers Disease

Intervention

Drug:
• Florbetapir F18
No Florbetapir F 18 will be administered in this study.

Locations

Country	Name	City	State
United States	Research Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)	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.	Scan acquired 50-60 min post-injection	No
Primary	Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)	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.	Scan acquired 50-60 min post-injection	No
Secondary	Change in Total Accuracy (MIMNeuro Software, All Readers)	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.	Scan acquired 50-60 min post-injection	No
Secondary	Change in Reliability (MIMNeuro Software)	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.	Scan acquired 50-60 min post-injection	No
Secondary	Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)	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.	Scan acquired 50-60 min post-injection	No
Secondary	Change in Reliability (Siemens Syngo.PET Software)	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.	Scan acquired 50-60 min post-injection	No