Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001482156
Ethics application status
Approved
Date submitted
17/10/2019
Date registered
28/10/2019
Date last updated
28/10/2019
Date data sharing statement initially provided
28/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Positron Emission Tomography of Oxidative Stress in Friedreich Ataxia
Scientific title
Non-invasive, in vivo neuroimaging of oxidative stress in Friedreich ataxia
Secondary ID [1] 299574 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Friedreich ataxia 314849 0
Condition category
Condition code
Neurological 313188 313188 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 313266 313266 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
- Intravenous bolus injection of 125MBq of 64Cu-ATSM, followed by PET scanning of the brain for up to 90mins.
- Single timepoint
Intervention code [1] 315830 0
Early Detection / Screening
Comparator / control treatment
This observational study will use a cross-sectional, between-group design. A comparator group of individuals who are not affected by Friedreich ataxia, and matched for demographic characteristics, will undergo the same procedures, allowing for between-group statistical comparison with the clinical cohort.
Control group
Active

Outcomes
Primary outcome [1] 321701 0
Standardised Uptake Value Ratio (SUVR) of 64Cu-ATSM binding in the dentate nuclei relative to the cerebral cortex estimated from the reconstructed PET scan after SUV equilibrium.
Timepoint [1] 321701 0
Single time-point
Primary outcome [2] 321702 0
Standardised Uptake Value Ratio (SUVR) of 64Cu-ATSM binding in the brainstem relative to the cerebral cortex estimated from the reconstructed PET scan after SUV equilibrium.
Timepoint [2] 321702 0
Single timepoint
Secondary outcome [1] 375946 0
Scale for the Assessment and Rating of Ataxias (SARA)
Timepoint [1] 375946 0
Single timepoint

Eligibility
Key inclusion criteria
- >18 years old
- Friedreich ataxia cohort: Genetically-confirmed diagnosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Neurological illnesses (other than Friedreich ataxia in the clinical cohort)
- Psychiatric illnesses requiring current pharmacotherapy
- Concussion in the past 12 months, or any history of major traumatic brain injury
- Pregnancy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
- Standardised uptake value ratios (SUVR) of the regions-of-interest (dentate nuclei and brainstem) will be calculated relative to the cerebral cortex.
- Between-group statistical inference will be undertaken using independent samples t-tests (or equivalent non-parametric Mann-Whitney U in the case of non-normality in the data).
- Linear correlations between SUVR values and clinical severity (SARA) will be undertaken using Pearson correlations (or equivalent non-parametric Spearman correlations in the event of non-normality in the data).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
Date of last participant enrolment
Anticipated
1/06/2020
Actual
Date of last data collection
Anticipated
1/06/2020
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304058 0
University
Name [1] 304058 0
Monash University
Country [1] 304058 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash Biomedical Imaging
770 Blackburn Road
Monash University
Victoria, 3800
Country
Australia
Secondary sponsor category [1] 304253 0
None
Name [1] 304253 0
None
Address [1] 304253 0
None
Country [1] 304253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304549 0
Monash University Human Research and Ethics Committee
Ethics committee address [1] 304549 0
Ethics committee country [1] 304549 0
Australia
Date submitted for ethics approval [1] 304549 0
Approval date [1] 304549 0
30/09/2019
Ethics approval number [1] 304549 0
18894

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

Contacts
Principal investigator
Name 97346 0
Dr Ian Harding
Address 97346 0
Monash Biomedical Imaging
770 Blackburn Road
Monash University, VIC, 3800
Country 97346 0
Australia
Phone 97346 0
+61 3 9905 9283
Fax 97346 0
Email 97346 0
ian.harding@monash.edu
Contact person for public queries
Name 97347 0
Ian Harding
Address 97347 0
Monash Biomedical Imaging
770 Blackburn Road
Monash University, VIC, 3800
Country 97347 0
Australia
Phone 97347 0
+61 3 9905 9283
Fax 97347 0
Email 97347 0
ian.harding@monash.edu
Contact person for scientific queries
Name 97348 0
Ian Harding
Address 97348 0
Monash Biomedical Imaging
770 Blackburn Road
Monash University, VIC, 3800
Country 97348 0
Australia
Phone 97348 0
+61 3 9905 9283
Fax 97348 0
Email 97348 0
ian.harding@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


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.