Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000386235
Ethics application status
Approved
Date submitted
6/02/2018
Date registered
15/03/2018
Date last updated
15/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Establishing an Australian reference range for patients with Parkinson’s disease
and healthy controls with F-DOPA Positron Emission Tomography.
Scientific title
Establishing an Australian reference range for striatal binding in patients with Parkinson’s disease and healthy controls with 6-[18F]fluoro-L-3,4-dihydroxyphenylalanine (F-DOPA) PET.
Secondary ID [1] 293972 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 306484 0
Condition category
Condition code
Neurological 305581 305581 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We propose to perform F-DOPA Positron Emission Tomography (PET) scans in 20 participants with typical clinical features of Parkinson’s disease (PD). Images will be compared to their standard care Magnetic Resonance Imaging (MRI) scans to identify brain structures. Previous MRI scans, performed within the last 12 months, will be selected for comparison to PET scans. All participants will be monitored for the duration of the PET scan appointment (approximately 4 hours). No additional follow-up will be performed on this study.
Intervention code [1] 300243 0
Not applicable
Comparator / control treatment
We propose to perform one F-DOPA Positron Emission Tomography (PET) scan and one Magnetic Resonance Imaging (MRI) scan on 10 healthy volunteer controls. MRI scans will be used to identify brain structures. The F-DOPA PET scan will be performed within 4 months of the MRI scan. Participants will be observed for 4 hours while attending the PET scan appointment and 1 hour during the MRI scan appointment. No additional follow-up will be performed on this study.
Control group
Active

Outcomes
Primary outcome [1] 304703 0
Difference in the striatoccipital ratio (SOR) between health controls and Parkinson's disease (PD) subjects by assessment of FDOPA brain activity on PET scans.
Timepoint [1] 304703 0
At completion of all subject imaging at the end of the study.
Secondary outcome [1] 342857 0
Estimate the diagnostic yield (sensitivity and specificity) of F-DOPA PET-CT scans in differentiating between normal healthy subjects and subjects with early and advanced-stage Parkinson's disease by assessing brain structures on MRI and brain activity on the FDOPA PET scan.
Timepoint [1] 342857 0
At completion of all subject imaging at the end of the study.
Secondary outcome [2] 343448 0
We will record any adverse events that occur in any group during the PET imaging process to assist in the assessment of the safety of F-DOPA PET imaging, although no adverse events from this procedure are anticipated..
Timepoint [2] 343448 0
At completion of all participant imaging.

Eligibility
Key inclusion criteria
Parkinson's disease: based on the UK Brain bank clinical criteria and a Hoehn and
Yahr score of 2.5 or less (early PD) or 3.0 or more (late PD).
Normal controls: aged matched individuals with no historical or clinical evidence of
any neurological disorder.
Greater than 18 years of age
Able to undertake PET imaging
Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy
Less than 18 years of age
Medical contraindication to PET or MRI imaging
Patients with concurrent psychiatric disorders, signs of severe cognitive deterioration and severe cardiovascular comorbidity.
Cognitive impairment considered to impair the ability to give written informed consent in the opinion of the treating clinician

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Based on previously published data from Groningen University Hospital, the mean contralateral striato-occipital ratio (SOR) was 2.69 (SD 0.27) in healthy controls compared with a mean of 2.09 (SD 0.14) in earlystage Parkinson's disease (PD). Assuming a difference of a similar magnitude in our participant population, we estimate a minimum sample size of 4 subjects to demonstrate a statistically significant difference in contralateral SOR between healthy controls and early-stage PD subjects with a power of 0.99 and type I error rate of 5% (2 sample, 1-sided t-test).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2018
Actual
Date of last participant enrolment
Anticipated
10/03/2020
Actual
Date of last data collection
Anticipated
10/03/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9957 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 18788 0
6000 - Perth
Recruitment postcode(s) [2] 18787 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 298604 0
Charities/Societies/Foundations
Name [1] 298604 0
Australian and New Zealand Socieity of Nuclear Medicine LTD
Country [1] 298604 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue, Nedlands, Western Australia 6009
Country
Australia
Secondary sponsor category [1] 297763 0
None
Name [1] 297763 0
Address [1] 297763 0
Country [1] 297763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299564 0
Sir Charles Gairdner and Osborne Park Health Care Group
Ethics committee address [1] 299564 0
Hospital Avenue, Nedlands, Western Australia 6009
Ethics committee country [1] 299564 0
Australia
Date submitted for ethics approval [1] 299564 0
28/03/2017
Approval date [1] 299564 0
29/05/2017
Ethics approval number [1] 299564 0
RGS0000000183

Summary
Brief summary
We propose to perform F-DOPA PET scans in 10 healthy volunteers and 20 participants with typical features of Parkinson’s disease (PD). Each will undergo an F-DOPA PET/CT scan. The healthy participants will also undergo an MRI scan to identify brain structures.
Analysis of these scans will allow us to estimate how sensitive this PET scan is in discriminating between Parkinson’s disease and healthy people with no evidence of Parkinson’s disease. The collected data will assist in establishing Australian reference ranges which will assist in future analysis of these PET scans for patients with Parkinson’s disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80854 0
Dr Nelson Loh
Address 80854 0
Charles Gairdner Hospital
WA PET Service/ Department of Nuclear Medicine
G Block, level 1
Hospital Ave
Nedlands, WA, 6009
Country 80854 0
Australia
Phone 80854 0
+61 08 6457 2322
Fax 80854 0
+61 08 6457 7422
Email 80854 0
Nelson.Loh@health.wa.gov.au
Contact person for public queries
Name 80855 0
Ms Elaine Campbell
Address 80855 0
Charles Gairdner Hospital
WA PET Service/ Department of Nuclear Medicine
G Block, level 1
Hospital Ave
Nedlands, WA, 6009
Country 80855 0
Australia
Phone 80855 0
+61 08 6457 2322
Fax 80855 0
+61 08 6457 7422
Email 80855 0
NuclearMedicineResearch.SCGH@health.wa.gov.au
Contact person for scientific queries
Name 80856 0
Ms Elaine Campbell
Address 80856 0
Charles Gairdner Hospital
WA PET Service/ Department of Nuclear Medicine
G Block, level 1
Hospital Ave
Nedlands, WA, 6009
Country 80856 0
Australia
Phone 80856 0
+61 08 6457 2322
Fax 80856 0
Email 80856 0
NuclearMedicineResearch.SCGH@health.wa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23602Ethical approval-999999  

Results publications and other study-related documents

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