Trial Outcomes & Findings for The Feasibility of Florbetapir Quantitation (NCT NCT01946243)

NCT ID: NCT01946243

Last Updated: 2015-06-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

96 participants

Primary outcome timeframe

Scan acquired 50-60 min post-injection

Results posted on

2015-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	96
Overall Study COMPLETED	96
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Feasibility of Florbetapir Quantitation

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Qualitative n=46 Participants Qualitative scan interpretation only	VisQ n=46 Participants Quantitation as an adjunct to qualitative scan interpretation	Change n=46 Participants Change = VisQ - Qualitative
Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)	81.7 Percent Accuracy Standard Error 2.4	88.8 Percent Accuracy Standard Error 3.1	7.1 Percent Accuracy Standard Error 1.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Qualitative n=46 Participants Qualitative scan interpretation only	VisQ n=46 Participants Quantitation as an adjunct to qualitative scan interpretation	Change n=46 Participants Change = VisQ - Qualitative
Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)	87.0 Percent Accuracy Standard Error 1.0	91.8 Percent Accuracy Standard Error 1.1	4.9 Percent Accuracy Standard Error 1.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Qualitative n=46 Participants Qualitative scan interpretation only	VisQ n=46 Participants Quantitation as an adjunct to qualitative scan interpretation	Change n=46 Participants Change = VisQ - Qualitative
Change in Total Accuracy (MIMNeuro Software, All Readers)	89.5 Percent Accuracy Standard Error 1.4	93.8 Percent Accuracy Standard Error 1.2	4.2 Percent Accuracy Standard Error 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Qualitative n=96 Participants Qualitative scan interpretation only	VisQ n=96 Participants Quantitation as an adjunct to qualitative scan interpretation	Change n=96 Participants Change = VisQ - Qualitative
Change in Reliability (MIMNeuro Software) All study cases	0.72 Fleiss Kappa Interval 0.71 to 0.737	0.79 Fleiss Kappa Interval 0.774 to 0.801	0.06 Fleiss Kappa Interval 0.018 to 0.112
Change in Reliability (MIMNeuro Software) Autopsy cases	0.73 Fleiss Kappa Interval 0.709 to 0.747	0.81 Fleiss Kappa Interval 0.787 to 0.825	0.08 Fleiss Kappa Interval 0.005 to 0.151
Change in Reliability (MIMNeuro Software) Non-autopsy cases	0.72 Fleiss Kappa Interval 0.7 to 0.737	0.77 Fleiss Kappa Interval 0.752 to 0.789	0.05 Fleiss Kappa Interval -0.013 to 0.113

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Qualitative n=46 Participants Qualitative scan interpretation only	VisQ n=46 Participants Quantitation as an adjunct to qualitative scan interpretation	Change n=46 Participants Change = VisQ - Qualitative
Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)	91.6 Percent Accuracy Standard Error 0.8	93.9 Percent Accuracy Standard Error 0.7	2.3 Percent Accuracy Standard Error 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Qualitative n=96 Participants Qualitative scan interpretation only	VisQ n=96 Participants Quantitation as an adjunct to qualitative scan interpretation	Change n=96 Participants Change = VisQ - Qualitative
Change in Reliability (Siemens Syngo.PET Software) All study cases	0.75 Fleiss Kappa Interval 0.738 to 0.761	0.82 Fleiss Kappa Interval 0.805 to 0.827	0.07 Fleiss Kappa Interval 0.007 to 0.125
Change in Reliability (Siemens Syngo.PET Software) Autopsy cases	0.76 Fleiss Kappa Interval 0.749 to 0.781	0.80 Fleiss Kappa Interval 0.785 to 0.817	0.04 Fleiss Kappa Interval -0.046 to 0.112
Change in Reliability (Siemens Syngo.PET Software) Non-autopsy cases	0.73 Fleiss Kappa Interval 0.718 to 0.749	0.83 Fleiss Kappa Interval 0.815 to 0.846	0.10 Fleiss Kappa Interval 0.008 to 0.187

Adverse Events

Florbetapir PET Scans

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chief Medical Officer

Avid Radiopharmaceuticals

Phone: 215-298-0700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place