The Feasibility of Florbetapir Quantitation

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01946243

Enrollment

Registered

2013-09-19

Start date

2013-08-31

Completion date

2014-04-30

Last updated

2015-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimers Disease

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.

Interventions

DRUGFlorbetapir F18

No Florbetapir F 18 will be administered in this study.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Florbetapir PET Scans No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07\[NCT00857415\]/A16\[NCT01447719\] and A17\[NCT01400425\]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).	96
Total	96

Baseline characteristics

Characteristic	Florbetapir PET Scans
Age, Continuous	76.9 years STANDARD_DEVIATION 10.23
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	92 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race/Ethnicity, Customized Asian	1 participants
Race/Ethnicity, Customized Black or African American	5 participants
Race/Ethnicity, Customized Other	1 participants
Race/Ethnicity, Customized White	89 participants
Region of Enrollment United States	96 participants
Sex: Female, Male Female	48 Participants
Sex: Female, Male Male	48 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

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.