Phase 3
Completed N=242
A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 Positron Emission Tomography (PET) Scan Interpretation
Source: ClinicalTrials.gov NCT03901092 ↗Enrolled (actual)
242
Serious AEs
—
Results posted
Aug 2020
Primary outcomePrimary: Primary Objective 1 Analysis 1: Diagnostic Performance of Individual Readers (NFT Score) — 91.5; 77.1; 89.4; 91.4 percentage of cases correctly identified
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the performance of physician readers trained to read flortaucipir-PET (positron emission tomography) scans.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Objective 1 Analysis 1: Diagnostic Performance of Individual Readers (NFT Score) |
91.5; 77.1; 89.4; 91.4; 87.2; 85.7 | — |
| PRIMARY Primary Objective 1 Analysis 2: Diagnostic Performance of Individual Readers (NIA-AA Autopsy Diagnosis) |
95.1; 70.7; 95.1; 85.4; 95.1; 82.9 | — |
| PRIMARY Primary Objective 2: Inter-reader Reliability of Reader Interpretation of Flortaucipir-PET Imaging |
95.0; 93.4; 94.6; 97.1; 97.1; 91.3 | — |
| SECONDARY Secondary Objective 1 Analysis 1: Diagnostic Performance of τAD++ Flortaucipir PET Images to Detect B3 NFTs |
87.2; 88.6; 80.9; 100.0; 76.6; 94.3 | — |
| SECONDARY Secondary Objective 1 Analysis 2: Diagnostic Performance of τAD++ Flortaucipir PET Images to Detect High ADNC |
92.7; 82.9; 85.4; 92.7; 85.4; 92.7 | — |
| SECONDARY Secondary Objective 2: Inter-reader Reliability of Reader Interpretation of τAD++ Flortaucipir PET Images |
92.5; 90.0; 91.3; 95.0; 91.7; 90.5 | — |
| SECONDARY Secondary Objective 3: Inter-reader Reliability of Flortaucipir PET Scan Interpretation in the Population of Intended Use |
97.5; 93.1; 95.6; 97.5; 93.1; 94.3 | — |
| SECONDARY Secondary Objective 4: Intra-reader Reliability of Reader Interpretation of Flortaucipir-PET Imaging |
95.0; 85.0; 80.0; 95.0; 90.0 | — |
Eligibility Criteria
Scan Reader Criteria (5 total):
- Board-certified in radiology or nuclear medicine
- Professional experience interpreting PET scans
- Naive to study protocol
- No previous training or exposure to Avid Flortaucipir F 18 read methodology
Scan Criteria:
- Previous enrollment in Study A05 confirmatory cohort (NCT02016560), or A16 (NCT02516046)
Scan Study Population Criteria for FR01 (A05 confirmatory cohort):
- Cognitively-impaired
- mild cognitive impairment (MCI) or dementia with suspected neurodegenerative cause
- mini-mental status exam (MMSE) score of 20-27, inclusive
Scan Study Population Criteria for FR01 (Study A16):
- Subjects at end of life (less than or equal to 6 months)
- Imaged with flortaucipir F18 and came to autopsy
Data sourced from ClinicalTrials.gov (NCT03901092). 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.