Trial Outcomes & Findings for The Feasibility of Florbetapir Quantitation in Europe (NCT NCT02107599)

Last Updated: 2015-07-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

96 participants

Primary outcome timeframe

Scan acquired 50-60 minutes post injection

Results posted on

2015-07-09

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 (A16\[NCT01447719\] and A17\[NCT01400425\]). Scans used in the study included 46 scans with autopsy (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 in Europe

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 (A16\[NCT01447719\] and A17\[NCT01400425\]). Scans used in the study included 46 scans with autopsy (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 minutes post injection

Outcome measures

Outcome measures
Measure	Physician Readers n=46 Participants All 21 physician readers.	Autopsy Cases Only 46 autopsy scans from A16.	Non-autopsy Cases Only 50 non-autopsy scans from A17.
Change in Reader Accuracy After Application of Quantitation Software	0.0746 Net Reclassification Index	—	—

SECONDARY outcome

Timeframe: Scan acquired 50-60 minutes post injection

Outcome measures

Outcome measures
Measure	Physician Readers n=96 Participants All 21 physician readers.	Autopsy Cases n=46 Participants Only 46 autopsy scans from A16.	Non-autopsy Cases n=50 Participants Only 50 non-autopsy scans from A17.
Change in Scan Interpretation Reliability After Application of Quantitation Software Kappa VisQ	0.73 Fleiss Kappa Interval 0.712 to 0.74	0.72 Fleiss Kappa Interval 0.703 to 0.743	0.73 Fleiss Kappa Interval 0.709 to 0.747
Change in Scan Interpretation Reliability After Application of Quantitation Software Kappa Qualitative	0.66 Fleiss Kappa Interval 0.647 to 0.675	0.66 Fleiss Kappa Interval 0.644 to 0.684	0.66 Fleiss Kappa Interval 0.638 to 0.676
Change in Scan Interpretation Reliability After Application of Quantitation Software Change in Kappa	0.06 Fleiss Kappa Interval 0.017 to 0.112	0.06 Fleiss Kappa Interval -0.015 to 0.132	0.07 Fleiss Kappa Interval 0.008 to 0.133

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