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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
Scientific title
A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 PET Scan Interpretation
Secondary ID [1] 0 0
18F-AV-1451-FR01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Objective 1 Analysis 1: Diagnostic Performance of Individual Readers (NFT Score)
Timepoint [1] 0 0
baseline scan
Primary outcome [2] 0 0
Primary Objective 1 Analysis 2: Diagnostic Performance of Individual Readers (NIA-AA Autopsy Diagnosis)
Timepoint [2] 0 0
baseline scan
Primary outcome [3] 0 0
Primary Objective 2: Inter-reader Reliability of Reader Interpretation of Flortaucipir-PET Imaging
Timepoint [3] 0 0
baseline scan
Secondary outcome [1] 0 0
Secondary Objective 1 Analysis 1: Diagnostic Performance of tAD++ Flortaucipir PET Images to Detect B3 NFTs
Timepoint [1] 0 0
baseline scan
Secondary outcome [2] 0 0
Secondary Objective 1 Analysis 2: Diagnostic Performance of tAD++ Flortaucipir PET Images to Detect High ADNC
Timepoint [2] 0 0
baseline scan
Secondary outcome [3] 0 0
Secondary Objective 2: Inter-reader Reliability of Reader Interpretation of tAD++ Flortaucipir PET Images
Timepoint [3] 0 0
baseline scan
Secondary outcome [4] 0 0
Secondary Objective 3: Inter-reader Reliability of Flortaucipir PET Scan Interpretation in the Population of Intended Use
Timepoint [4] 0 0
baseline scan
Secondary outcome [5] 0 0
Secondary Objective 4: Intra-reader Reliability of Reader Interpretation of Flortaucipir-PET Imaging
Timepoint [5] 0 0
baseline scan

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/04/2019
Sample size
Target
Accrual to date
Final
242
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Avid Radiopharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the performance of physician readers trained to read
flortaucipir-PET (positron emission tomography) scans.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03901092
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Avid Radiopharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries