Phase 4
Completed N=96
The Feasibility of Florbetapir Quantitation in Europe
Source: ClinicalTrials.gov NCT02107599 ↗Enrolled (actual)
96
Serious AEs
—
Results posted
Jul 2015
Primary outcomePrimary: Change in Reader Accuracy After Application of Quantitation Software — 0.0746 Net Reclassification Index — p=0.0001
Summary
This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Reader Accuracy After Application of Quantitation Software |
0.0746 | 0.0001 sig |
| SECONDARY Change in Scan Interpretation Reliability After Application of Quantitation Software |
0.73; 0.72; 0.73; 0.66; 0.66; 0.66 | 0.0060 sig |
Eligibility Criteria
Inclusion Criteria
- Readers have undergone Amyvid reader training
- Readers have not more than minimal experience with quantitation of amyloid PET scans
Exclusion Criteria
- Readers have previously been trained to quantitate amyloid PET scans
Data sourced from ClinicalTrials.gov (NCT02107599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.