Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
[email protected]
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
[email protected]
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
[email protected]

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.