Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001273572p
Ethics application status
Submitted, not yet approved
Date submitted
24/09/2024
Date registered
18/10/2024
Date last updated
18/10/2024
Date data sharing statement initially provided
18/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Evaluation of Amyloid Positron Emission Tomography (PET) for Alzheimer’s Disease Assessment
Scientific title
Clinical Evaluation of the Added Benefits of Amyloid Positron Emission Tomography (Amyloid-PET) Scans in Cases with Equivocal Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Results for Alzheimer’s Disease Assessment
Secondary ID [1] 313039 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer’s disease 335262 0
Condition category
Condition code
Neurological 331833 331833 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a prospective, non-randomised, non-blinded feasibility assessment aimed at determining whether a new type of brain scan called an Amyloid (18F-Florbetaben) Positron Emission Tomography/Computed Tomography (Amyloid PET/CT) scan can provide additional benefits in diagnosing Alzheimer’s disease. This scan may be particularly useful in cases where other tests, including clinical assessments and the commonly used Fluorodeoxyglucose (FDG) PET/CT scan, have not provided clear diagnostic results. Participation in this study involves one imaging scan outside of standard care: the Amyloid PET/CT scan.
The Amyloid PET/CT scan will be performed at I-MED Radiology, The Wesley Hospital (Brisbane), and interpreted by a nuclear medicine radiologist involved in this study. The total time required for the scan process is approximately 3 hours. Each patient will receive 300 MBq (+/-10%) of the Florbetaben tracer via intravenous cannulation, administered 90 minutes before the PET/CT scan. The scan itself will take approximately 20 minutes to complete.
Intervention code [1] 329592 0
Diagnosis / Prognosis
Comparator / control treatment
Participant's own most recent FDG PET/CT scan
Control group
Active

Outcomes
Primary outcome [1] 339454 0
Proportion of patients for whom the Amyloid PET/CT scan provides additional diagnostic information, leading to a more definitive diagnosis or exclusion of Alzheimer’s disease.
Timepoint [1] 339454 0
Typically within 2 weeks of the Amyloid PET/CT scan and multidisciplinary review.
Secondary outcome [1] 440044 0
Correlation between the visual interpretation of Amyloid PET/CT scans (positive or negative) and the semi-quantitative analysis (tracer uptake value) using syngo.via software.
Timepoint [1] 440044 0
At the end of the study, once all participants have undergone the scans.

Eligibility
Key inclusion criteria
Inclusion criteria:
• Aged 18 years or older
• Have undergone FDG PET/CT brain imaging as part of routine Alzheimer's disease evaluation and received equivocal results
• Deemed eligible by the Wesley NeuroPET Multidisciplinary team (MDT) for study participation
• Willing and physically able to undergo an additional Amyloid PET/CT scan as per study protocol
• Has adequate renal function (eGFR >30 mL/min/1.73 m²)
• Willing and able to provide informed consent (or consent may be provided through a surrogate) to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
• Aged younger than 18 years
• Have undergone FDG PET/CT brain imaging as part of routine Alzheimer's disease evaluation and received conclusive results
• Known allergies or contraindications to the components used in PET imaging.
• Significant medical conditions or comorbidities that could interfere with study participation or pose a risk during PET scanning
• History of other neurological disorders or conditions that may confound the interpretation of amyloid PET/CT results
• Current participation in other clinical trials involving investigational drugs or interventions that could affect study outcomes
• Inability to comply with study procedures due to logistical or other reasons
• Pregnant or breastfeeding

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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/10/2024
Actual
Date of last participant enrolment
Anticipated
21/10/2026
Actual
Date of last data collection
Anticipated
31/10/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317481 0
Charities/Societies/Foundations
Name [1] 317481 0
Wesley Research Institute
Country [1] 317481 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
I-MED Radiology Network
Address
Country
Australia
Secondary sponsor category [1] 319773 0
None
Name [1] 319773 0
Address [1] 319773 0
Country [1] 319773 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316195 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 316195 0
Ethics committee country [1] 316195 0
Australia
Date submitted for ethics approval [1] 316195 0
07/05/2024
Approval date [1] 316195 0
Ethics approval number [1] 316195 0

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

Contacts
Principal investigator
Name 137098 0
Dr David Wong
Address 137098 0
I-MED Radiology Network, The Wesley Hospital, 30 Chasely St, Auchenflower, Brisbane QLD 4066
Country 137098 0
Australia
Phone 137098 0
+61419701900
Fax 137098 0
Email 137098 0
david.wong@i-med.com.au
Contact person for public queries
Name 137099 0
Sepinoud Firouzmand
Address 137099 0
Wesley Specialist Centre, Level 1 (I-MED Radiology Network), 87 Lang Pde, Auchenflower QLD 4066
Country 137099 0
Australia
Phone 137099 0
+61 7 3371 9588
Fax 137099 0
Email 137099 0
research@i-med.com.au
Contact person for scientific queries
Name 137100 0
Sepinoud Firouzmand
Address 137100 0
Wesley Specialist Centre, Level 1 (I-MED Radiology Network), 87 Lang Pde, Auchenflower QLD 4066
Country 137100 0
Australia
Phone 137100 0
+61 7 3371 9588
Fax 137100 0
Email 137100 0
research@i-med.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Any data that is published will be fully anonymised to ensure the privacy and confidentiality of participants is maintained.


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.