Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000067673
Ethics application status
Approved
Date submitted
4/12/2022
Date registered
20/01/2023
Date last updated
20/01/2023
Date data sharing statement initially provided
20/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
64CuATSM Positron Emission Tomography with Quantitative Susceptibility Mapping Magnetic Resonance Imaging as a Biomarker of Motor Neurone Disease
Scientific title
64CuATSM Positron Emission Tomography with Quantitative Susceptibility Mapping Magnetic Resonance Imaging as a Biomarker of Motor Neurone Disease in Adults with Limb Onset Variant
Secondary ID [1] 308543 0
none
Universal Trial Number (UTN)
Trial acronym
CuATSM with QSM in MND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
motor neurone disease 328391 0
Condition category
Condition code
Neurological 325418 325418 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a cross-sectional exploratory neuroimaging biomarker study. Following informed consent, clinical data (diagnosis, disease parameters, cognitive data) will be obtained. Participants will have one brain PET/MRI scan which will be acquired at Monash Biomedical Imaging in Clayton, VIC. PET imaging will consist of a an intravenous bolus of up to 200 MBq of 64Cu(ATSM) over 60s followed by up to 90min dynamic acquisition of the PET image. MRI imaging will comprise both a volumetric image and a quantitative susceptibility mapping (QSM) image acquired during the same session. Blood will be collected for measurement of other markers of neurodegeneration and oxidative stress, including neurofilament light chain, isoprostanes, and acute phase proteins. Imaging will be conducted by trained staff at Monash Biomedical Imaging. Clinical data will be collected by study physicians.
Intervention code [1] 324989 0
Diagnosis / Prognosis
Comparator / control treatment
Imaging parameters from this study will be compared to 64CuATSM PET uptake and MRI QSM signal in a health control cohort using data obtained from studies in 2020-2 at Monash Biomedical Imaging.
Control group
Historical

Outcomes
Primary outcome [1] 333281 0
Region of interest 64CuATSM PET signal / control region uptake value in subjects will be compared to region of interest 64CuATSM PET signal / control region uptake value in an existing control group.
Timepoint [1] 333281 0
This is a cross-sectional study. PET/MRI scans and clinical data will be collected once only on the day of enrollment.
Secondary outcome [1] 416462 0
MRI quantitative susceptibility mapping (QSM) signal
QSM signal will be determined using validated automated methods, e.g. the JHU/KKI QSM Toolbox V3.0.
Timepoint [1] 416462 0
This is a cross-sectional study. Scanning will take place once only on the on the day of enrolment.

Eligibility
Key inclusion criteria
limb onset variant of motor neurone disease / amyotrophic lateral sclerosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) presence of other known neurological or psychiatric diseases which may cause MRI changes
2) history of learning disability / intellectual disability
3) unable to tolerate PET or MRI scanning
4) diagnosis of dementia

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
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/02/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312792 0
Government body
Name [1] 312792 0
NHMRC (Investigator Grant)
Country [1] 312792 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Florey Institute of Neuroscience and Mental Health
Address
30 Royal Parade
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 314426 0
None
Name [1] 314426 0
Address [1] 314426 0
Country [1] 314426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312079 0
Barwon Health
Ethics committee address [1] 312079 0
Ethics committee country [1] 312079 0
Australia
Date submitted for ethics approval [1] 312079 0
23/02/2021
Approval date [1] 312079 0
03/03/2021
Ethics approval number [1] 312079 0
19/100

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123394 0
A/Prof Paul Talman
Address 123394 0
Neurosciences
Health Wing, Level 2
University Hospital Geelong
Bellerine St
Geelong VIC 3220
Country 123394 0
Australia
Phone 123394 0
+61 3 4215 2274
Fax 123394 0
Email 123394 0
neuroscience@barwonhealth.org.au
Contact person for public queries
Name 123395 0
Andrew Gleason
Address 123395 0
Florey Institute of Neuroscience and Mental Health
30 Royal Parade
Parkville VIC 3052
Country 123395 0
Australia
Phone 123395 0
+61 3 9035 6532
Fax 123395 0
Email 123395 0
andrew.gleason@monash.edu
Contact person for scientific queries
Name 123396 0
Andrew Gleason
Address 123396 0
Florey Institute of Neuroscience and Mental Health
30 Royal Parade
Parkville VIC 3052
Country 123396 0
Australia
Phone 123396 0
+61 3 9035 6532
Fax 123396 0
Email 123396 0
andrew.gleason@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
Raw data will not be made publicly available. Outcomes will be submitted to a peer-reviewed journal.


What supporting documents are/will be available?

No Supporting Document Provided



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.