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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03901092
Registration number
NCT03901092
Ethics application status
Date submitted
27/03/2019
Date registered
3/04/2019
Date last updated
9/09/2020
Titles & IDs
Public title
A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 Positron Emission Tomography (PET) Scan Interpretation
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Scientific title
A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 PET Scan Interpretation
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Secondary ID [1]
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18F-AV-1451-FR01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - flortaucipir F 18
Experimental: Flortaucipir PET Scan - Scans previously acquired from Study A16 (NCT02516046) and A05 (NCT02016560) will be read by independent, blinded readers.
Treatment: Drugs: flortaucipir F 18
No study drug will be administered.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary Objective 1 Analysis 1: Diagnostic Performance of Individual Readers (NFT Score)
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Assessment method [1]
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Sensitivity and specificity of 5 independent readers' interpretations of ante-mortem 18F-AV-1451 PET imaging for detection of a pattern of 18F-AV-1451 neocortical uptake that corresponds to neurofibrillary tangles (NFT) Score of B3 (Hyman et al., 2012; Montine et al., 2012). NFT B scores range from B0 (no NFTs in the brain) to B3 (widespread NFTs in the brain). Sensitivity and specificity are percentages that can range from 0 to 100%. The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% CIs =50%, for both sensitivity and specificity.
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Timepoint [1]
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baseline scan
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Primary outcome [2]
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Primary Objective 1 Analysis 2: Diagnostic Performance of Individual Readers (NIA-AA Autopsy Diagnosis)
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Assessment method [2]
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Sensitivity and specificity of 5 independent readers' interpretations of ante-mortem 18F-AV-1451 PET imaging for detection of a pattern of 18F-AV-1451 neocortical uptake that corresponds to high levels of AD neuropathologic change (High ADNC) as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (see Hyman et al. 2012). ADNC categories are None, Low, Intermediate and High, with High indicating the most severe level of AD-related pathology changes in the brain. The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% CIs =50%, for both sensitivity and specificity.
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Timepoint [2]
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baseline scan
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Primary outcome [3]
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Primary Objective 2: Inter-reader Reliability of Reader Interpretation of Flortaucipir-PET Imaging
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Assessment method [3]
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As measured by Fleiss' Kappa across all scans read. Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. Fleiss' kappa can range from 0 to 1 with 1 indicating perfect agreement between the readers. Scan results binarized as positive AD pattern versus negative AD pattern. Results are displayed as percentage of agreement for individual reader pairs, computed as follows: number of images for which reader had the same interpretation divided by the total number of images evaluated, multiplied by 100%.
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Timepoint [3]
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baseline scan
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Secondary outcome [1]
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Secondary Objective 1 Analysis 1: Diagnostic Performance of tAD++ Flortaucipir PET Images to Detect B3 NFTs
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Assessment method [1]
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Flortaucipir F 18 PET imaging will be classified by each reader as either neocortical uptake not consistent with AD (tAD-), neocortical uptake consistent with AD (tAD+), or neocortical uptake consistent with AD with uptake beyond the temporal/occipital regions (tAD++). NFT scoring is according to Hyman, et al 2012. Truth positive is a NFT B3 score. Truth negative is NFT <B3 score.
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Timepoint [1]
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baseline scan
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Secondary outcome [2]
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Secondary Objective 1 Analysis 2: Diagnostic Performance of tAD++ Flortaucipir PET Images to Detect High ADNC
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Assessment method [2]
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Sensitivity and specificity of 5 independent readers' interpretations of ante-mortem 18F-AV-1451 PET imaging for detection of a pattern of 18F-AV-1451 neocortical uptake that corresponds to high levels of AD neuropathologic change (High ADNC) as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (Hyman et al. 2012). Truth positive is a High ADNC score. Truth negative is No/Low/Intermediate ADNC score.
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Timepoint [2]
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baseline scan
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Secondary outcome [3]
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Secondary Objective 2: Inter-reader Reliability of Reader Interpretation of tAD++ Flortaucipir PET Images
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Assessment method [3]
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Overall reader agreement as measured by Fleiss' Kappa statistic. Scan results binarized as tAD++ versus tAD+/tAD-. Results are displayed as percentage of agreement for individual reader pairs, computed as follows: number of images for which reader had the same interpretation divided by the total number of images evaluated, multiplied by 100%.
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Timepoint [3]
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baseline scan
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Secondary outcome [4]
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Secondary Objective 3: Inter-reader Reliability of Flortaucipir PET Scan Interpretation in the Population of Intended Use
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Assessment method [4]
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Reader agreement measured by Fleiss' Kappa across scans from non-autopsy cases from Study A05. Scan results binarized as positive for AD pattern versus negative for AD pattern. Results are displayed as percentage of agreement for individual reader pairs, computed as follows: number of images for which reader had the same interpretation divided by the total number of images evaluated, multiplied by 100%.
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Timepoint [4]
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baseline scan
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Secondary outcome [5]
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Secondary Objective 4: Intra-reader Reliability of Reader Interpretation of Flortaucipir-PET Imaging
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Assessment method [5]
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Cohen's Kappa will be calculated for each of 5 readers to assess the intra-reader reliability of flortaucipir F 18 PET scan visual interpretation. The statistic takes into account the possibility of the agreement occurring by chance. Cohen's kappa values range from 0 to 1 with 1 representing perfect agreement. Results are displayed as percentage of agreement within a reader, computed as follows: number of images for which reader had the same interpretation at initial and second read divided by the total number of images evaluated twice by a reader, multiplied by 100%.
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Timepoint [5]
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baseline scan
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Eligibility
Key inclusion 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/04/2019
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Sample size
Target
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Accrual to date
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Final
242
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Pennsylvania
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Avid Radiopharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the performance of physician readers trained to read flortaucipir-PET (positron emission tomography) scans.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03901092
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Study Director
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Address
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Avid Radiopharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT03901092
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