Trial Outcomes & Findings for Evaluation of Reader Training Processes (NCT NCT02051790)
NCT ID: NCT02051790
Last Updated: 2015-09-28
Results Overview
Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
241 participants
Primary outcome timeframe
Scan acquired 50-60 minutes post injection
Results posted on
2015-09-28
Participant Flow
Participant milestones
| Measure |
Clinical Practice Scans
241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.
florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice.
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|---|---|
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Overall Study
STARTED
|
241
|
|
Overall Study
COMPLETED
|
241
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Reader Training Processes
Baseline characteristics by cohort
| Measure |
Clinical Practice Scans
n=241 Participants
241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.
florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice.
|
|---|---|
|
Age, Customized
Age Unknown
|
241 scans
n=5 Participants
|
|
Sex/Gender, Customized
Gender Unknown
|
241 scans
n=5 Participants
|
|
Region of Enrollment
United States
|
241 scans
n=5 Participants
|
PRIMARY outcome
Timeframe: Scan acquired 50-60 minutes post injectionAgreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.
Outcome measures
| Measure |
Clinical Practice Scans
n=241 Participants
241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.
florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice.
|
|---|---|
|
Agreement Between Expert Panel and Clinical Practice Reads
|
0.745 Weighted Kappa statistic
Interval 0.6649 to 0.826
|
Adverse Events
Clinical Practice 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place