Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001204932
Ethics application status
Approved
Date submitted
17/09/2020
Date registered
12/11/2020
Date last updated
12/11/2020
Date data sharing statement initially provided
12/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Imaging Tau in Patients with Progressive Supra-Nuclear Palsy with [18F]PI-2620 PET
Scientific title
Imaging Tau in Patients with Progressive Supra-Nuclear Palsy with [18F]PI-2620 PET
Secondary ID [1] 302338 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
progressive supranuclear palsy
 319110 0
Condition category
Condition code
Neurological 317069 317069 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
New PET radiotracer, PI-2620, 185MBq, intravenous. Single administration by certified nuclear medicine technologist. Potential new diagnostic tool. Patients will undergo a single PET scan (duration 60 minutes), the scan will start concurrently with injection of the radiotracer.
Intervention code [1] 318630 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325160 0
Binding potential in basal ganglia (derived from PET image)
Timepoint [1] 325160 0
0-60min post injection
Secondary outcome [1] 387048 0
SUV measurement in basal ganglia (derived from PET image)
Timepoint [1] 387048 0
0-60 min post injection
Secondary outcome [2] 387898 0
Relationship between PET measures and disease severity.

PET measures (SUV and binding potential) in the basal ganglia will be correlated with disease severity (measured by the PSPRS).
The PSPRS is a clinician administered scale of presence and severity of PSP symptoms
Timepoint [2] 387898 0
Day of scan (PSPRS will be measured approx 1-2 hours prior to PET scan.

Eligibility
Key inclusion criteria
Diagnosed with probable Progressive Supranuclear Palsy (MDS criteria)
Not pregnant/breastfeeding
Stable PSP medications for previous 30 days
Able to provide written informed consent
Minimum age
40 Years
Maximum age
86 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unstable medical condition that could impact participant safety or completion of study procedures
2. Subject having received an investigational treatment targeting tau or amyloid within 3 months of imaging visit.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
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
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Image derived measures of uptake and binding in specific brain regions will be collated for different brain regions. Paired, non-parametric statistics will be used to determine differences in PET measures between brain regions.
Correlation analyses will be performed to investigate relationships between PET measurements and disease severity (measured by the PSP rating scale)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/06/2020
Date of last participant enrolment
Anticipated
Actual
6/10/2020
Date of last data collection
Anticipated
Actual
6/10/2020
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17549 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 31284 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 306767 0
Commercial sector/Industry
Name [1] 306767 0
Life Molecular Imaging
Country [1] 306767 0
Switzerland
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road
Melbourne
3004 VIC
Country
Australia
Secondary sponsor category [1] 307320 0
None
Name [1] 307320 0
Address [1] 307320 0
Country [1] 307320 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306932 0
Alfred Health HREC
Ethics committee address [1] 306932 0
55 Commercial Road
Melbourne
3004 VIC
Ethics committee country [1] 306932 0
Australia
Date submitted for ethics approval [1] 306932 0
12/12/2019
Approval date [1] 306932 0
19/02/2020
Ethics approval number [1] 306932 0
608/19

Summary
Brief summary
The study will investigate a new PET radiotracer PI-2620 to see if it can visual the tau protein which is observed in the brains of patients with progressive supranuclear palsy (PSP). The tau protein builds up in certain brain areas in patients with PSP, such as the basal ganglia. We hypothesise that PI-2620 will show high levels of uptake in the basal ganglia, indicating the presence of tau.
Patients will undergo a single PET scan, whereby we inject a small amount of the radiotracer. The patient will then be scanned for 60 minutes. The resulting image will then show whether or not the radiotracer binds in the basal ganglia (indicating tau accumulation). The amount of tau in the basal ganglia can be measured from these images and we will then establish whether the levels of tau increase with increasing severity of PSP symptoms.
If successful this radiotracer could be used in the future to help diagnose PSP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105494 0
Prof Terence O'Brien
Address 105494 0
Level 6 The Alfred Centre,
99 Commercial Road
Melbourne
3004 VIC
Country 105494 0
Australia
Phone 105494 0
+61 3 99030855
Fax 105494 0
Email 105494 0
te.obrien@alfred.org.au
Contact person for public queries
Name 105495 0
Lucy Vivash
Address 105495 0
Level 6 The Alfred Centre,
99 Commercial Road
Melbourne
3004 VIC
Country 105495 0
Australia
Phone 105495 0
+61 3 9903 0860
Fax 105495 0
Email 105495 0
lucy.vivash@monash.edu
Contact person for scientific queries
Name 105496 0
Lucy Vivash
Address 105496 0
Level 6 The Alfred Centre,
99 Commercial Road
Melbourne
3004 VIC
Country 105496 0
Australia
Phone 105496 0
+61 3 9903 0860
Fax 105496 0
Email 105496 0
lucy.vivash@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Commercial in confidence.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9183Study protocol  lucy.vivash@monash.edu
9185Ethical approval    380609-(Uploaded-17-09-2020-13-34-25)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.