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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000208303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/11/2025
Date registered
Help: Date registered
19/02/2026
Date last updated
Help: Date last updated
18/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
19/02/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Finding the fibril in the haystack: A pilot study of Amyloid ([18F] Florbetaben) PET-CT in Peripheral Nerve Amyloidosis
Scientific title
Finding the fibril in the haystack: A pilot study of Amyloid ([18F] Florbetaben) PET-CT in Peripheral Nerve Amyloidosis
Additional trial identifiers [1] 316019 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Amyloidosis 339855 0
Peripheral Neuropathy 339856 0
Condition category
Condition code
Neurological 336091 336091 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This pilot study is a cross-sectional study to evaluate the utility of [18F] Florbetaben-PET to evaluate peripheral nerve and whole-body amyloid uptake.

Whole-body [18F]Florbetaben PET-CT scans will be performed in 25 individuals (20 participants and 5 healthy controls) recruited from Westmead and St Vincent’s Amyloidosis Centres. Five patients will be recruited for each amyloid neuropathy pattern, including: Length-dependent large fibre neuropathy, Plexopathy or Mononeuritis multiplex, Isolated small fibre and autonomic neuropathy and wildtype tranthyretin amyloidosis (ATTRwt) with neuropathy, not explained by an alternate aetiology. The five healthy controls will be recruited from family members of participants attending appointments at the Amyloidosis Centre, and staff from each Amyloidosis centres. Participants will be phenotyped including evaluation of their clinical history, examination findings, investigations, and both clinical and organ staging, as part of their routine clinical care. This routine testing includes clinical staging scores, examination, blood testing, echocardiogram, cardiac bone-scintigraphy and nerve conduction studies.

All participants will visit the Australian National Total Body PET Facility for a single whole-body [18F] Florbetaben PET/CT scan. Standard clinical procedures will be followed using the Siemens Biograph Vision Quadra PET/CT scanner. The imaging agent, [18F]Florbetaben (150 ± 10% MBq), will be administered by a radiologist or radiographer as a bolus intravenous injection 90 minutes prior to imaging to allow for maximum specific binding to amyloid deposits and achieve optimal signal-to-background ratio.

Following injection, participants will rest in a quiet uptake room. After the 90-minute uptake period, they will be positioned supine on the scanning bed, instructed to remain still and breathe normally. A low-dose CT scan (120 kVp, Qref 40 mAs intensity modulation with DoseCare4D) will be performed for anatomical localization and attenuation correction of the PET data. Following the CT scan, a short 10-minute whole-body PET acquisition will be performed. Post scan care will include removal of the intravenous cannula. Participants will be checked to ensure they are not adversely affected.
Intervention code [1] 332626 0
Diagnosis / Prognosis
Description of the comparator or control
5 healthy control participants will be recruited for Whole-body [18F]Florbetaben PET-CT scanning to identify any background uptake of Florbetaben occurs in the general population.
Control group
Active

Outcomes
Primary outcome [1] 343634 0
Florbetaben uptake in peripheral nerve amyloid deposits
Timepoint [1] 343634 0
After a single [18F]Florbetaben PET/CT scan
Secondary outcome [1] 454986 0
Regional patterns of amyloid burden in AL Amyloidosis
Timepoint [1] 454986 0
After a single [18F]Florbetaben PET/CT scan
Secondary outcome [2] 454987 0
Regional patterns of amyloid burden in ATTR Amyloidosis
Timepoint [2] 454987 0
After a single [18F]Florbetaben PET/CT scan
Secondary outcome [3] 454988 0
Organ Florbetaben uptake compared to standard staging investigations
Timepoint [3] 454988 0
After a single [18F]Florbetaben PET/CT scan
Secondary outcome [4] 457722 0
Quantification of global amyloid burden
Timepoint [4] 457722 0
After a single [18F]Florbetaben PET/CT scan

Eligibility
Key inclusion criteria
Inclusion criteria Interventional group:
1. Adults between 18 and 90 years of age
2. Confirmed or suspected light chain (AL) or transthyretin (TTR) amyloidosis, meeting diagnostic criteria for one of the following categories:
a. Length-dependent large fibre neuropathy
b. Plexopathy or Mononeuritis multiplex
c. Isolated small fibre and autonomic neuropathy
d. ATTR wildtype (ATTRwt) with neuropathy, not explained by an alternate aetiology
3. Willingness to provide written informed consent and willingness to participate and comply with the study requirements.

Inclusion criteria control group:
1. Adults between 18 and 90 years of age
2. No evidence of neuropathy
3. Willingness to provide written informed consent and willingness to participate and comply with the study requirements
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Exclusion criteria for Intervention and control groups:
1. Pre-existing neuropathy of alternate aetiology
2. Significant renal or hepatic impairment that may affect tracer metabolism and clearance.
3. Use of investigational anti-amyloid therapies within the past 6 months.
4. Unstable cardiovascular disease, including recent myocardial infarction (=6 months) or uncontrolled arrhythmias.
5. Active malignancy or history of cancer requiring treatment within the past 6 months
6. Active systemic infection or inflammatory disease that could cause non-specific tracer uptake.
7. Severe claustrophobia or inability to remain supine for imaging.
8. Pregnancy or breastfeeding
9. Body weight exceeding scanner limitations (>200 kg).
10. Recent chemotherapy or radiation therapy (<6 weeks prior to imaging) that may alter amyloid burden.
11. Inability to provide informed consent or cognitive impairment affecting study participation.
12. History of severe psychiatric illness that may interfere with study compliance.

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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/03/2026
Actual
15/06/2026
Date of last participant enrolment
Anticipated
1/06/2027
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
25
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28826 0
Westmead Hospital - Westmead
Recruitment hospital [2] 28827 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 45062 0
2145 - Westmead
Recruitment postcode(s) [2] 45063 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 320618 0
Charities/Societies/Foundations
Name [1] 320618 0
Brain Foundation of Australia
Country [1] 320618 0
Australia
Funding source category [2] 320622 0
University
Name [2] 320622 0
University of Sydney - Total Body PET Pilot Study Seed Funding Scheme
Country [2] 320622 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 323242 0
None
Name [1] 323242 0
Address [1] 323242 0
Country [1] 323242 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319158 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 319158 0
Ethics committee country [1] 319158 0
Australia
Date submitted for ethics approval [1] 319158 0
16/05/2025
Approval date [1] 319158 0
28/07/2025
Ethics approval number [1] 319158 0
2025/ETH01055

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

Contacts
Principal investigator
Name 146442 0
Dr Antonia Carroll
Address 146442 0
Brain and Mind Centre, 94 Mallett St, Camperdown, NSW, 2050
Country 146442 0
Australia
Phone 146442 0
+61 2 9114 4252
Fax 146442 0
Email 146442 0
[email protected]
Contact person for public queries
Name 146443 0
Antonia Carroll
Address 146443 0
Brain and Mind Centre, 94 Mallett St, Camperdown, NSW, 2050
Country 146443 0
Australia
Phone 146443 0
+61 2 9114 4252
Fax 146443 0
Email 146443 0
[email protected]
Contact person for scientific queries
Name 146444 0
Antonia Carroll
Address 146444 0
Brain and Mind Centre, 94 Mallett St, Camperdown, NSW, 2050
Country 146444 0
Australia
Phone 146444 0
+61 2 9114 4252
Fax 146444 0
Email 146444 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Not approved by HREC



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.