Trial Review

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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
ACTRN12624000755538
Ethics application status
Approved
Date submitted
5/06/2024
Date registered
19/06/2024
Date last updated
19/06/2024
Date data sharing statement initially provided
19/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Positron Emission Tomography with AT-01 to Diagnose and Monitor Amyloidosis: A Prospective Cohort Pilot Study.
Scientific title
Positron Emission Tomography with AT-01 to Diagnose and Monitor Amyloidosis: A Prospective Cohort Pilot Study in Adult Patients.
Secondary ID [1] 312196 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyloidosis 333864 0
Condition category
Condition code
Blood 330539 330539 0 0
Haematological diseases
Cardiovascular 330540 330540 0 0
Other cardiovascular diseases
Metabolic and Endocrine 330755 330755 0 0
Other metabolic disorders
Neurological 330757 330757 0 0
Other neurological disorders
Oral and Gastrointestinal 330759 330759 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
If participants enrol in the study they will undergo PET-CT imaging with AT-01 to assess if it is able to diagnose organ involvement of systemic amyloidosis and give an indication of systemic amyloid burden. 2 scans will be performed; initially at diagnosis and repeated after 6-12 months post standard of care treatment.

Participants will consent to having two additional scans performed in addition to their usual standard of care and to de-identified data collection.

Females of childbearing age will need to undergo pregnancy screening (urine or blood) within 72 hours of each scan.

Imaging will be performed within the nuclear medicine department of the respective hospitals under the care of an experienced nuclear physician team. The compound will be diluted with 10ml of saline and administered via IV push method at a rate of 1ml/5 seconds. The exact time of calibration of the dose will be recorded using a global time piece
consistently used throughout the study for time recording (internet time). The exact start time of infusions/injections are to be noted and recorded to permit correction of the administered dose for radioactive decay. The dose calibrator and PET/CT scanner clocks will be synchronized. Image acquisition starts 5 hours post tracer administration. A Low dose CT scan for attenuation correction and co-registration will be performed. Imaging will include vertex to mid-thigh, scan in the caudal-cranial direction. Five minutes per bed position will be used with the exception of the bed position over the heart which will be acquired for ten minutes resulting in a scan that lasts 45 minutes in total. Subject will lay supine with arms by their sides for imaging.
Intervention code [1] 328642 0
Diagnosis / Prognosis
Intervention code [2] 328801 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338306 0
Systemic amyloidosis
Timepoint [1] 338306 0
Baseline and between 6-12 months post initial scan
Primary outcome [2] 338446 0
Diagnose the presence and extent of systemic amyloidosis organ involvement
Timepoint [2] 338446 0
Baseline scan at diagnosis
Primary outcome [3] 338447 0
Determine if the change in organ specific amyloid burden using AT-01 PET/CT imaging,
Timepoint [3] 338447 0
Baseline and 12 months post baseline scan,
Secondary outcome [1] 435969 0
Correlation between AT-01 PET/CT defined response or progression and standard amyloidosis response or progression definitions.
Timepoint [1] 435969 0
Baseline and 12 months post baseline scan,
Secondary outcome [2] 435972 0
Adverse events and tolerability of AT-01 PET/CT imaging
Timepoint [2] 435972 0
From day of scan to 7 days post for both baseline and follow up scans.

Eligibility
Key inclusion criteria
1. Diagnosis of amyloidosis with the known following subtype:
(a) Systemic AL amyloidosis prior to therapy commencement (n=15)
(b) Systemic AL amyloidosis with suboptimal response to therapy or in early biochemical relapse (n=5)
(c) ATTRwt amyloidosis (n=5)
(d) Other systemic amyloidosis i.e. ALECT2 and Alys amyloidosis (n=5)
2. Age equal to or greater than 18yrs
3. Life expectancy greater than 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Localised amyloidosis
2. Known iodine or potassium iodide hypersensitivity
3. Patients being treated with heparin and heparin like anticoagulant therapy (due to interaction with AT-01)
4. Patients who are pregnant and/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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Given the small numbers and exploratory nature of this study statistics will be descriptive. Comparative statistical analyses will not be performed but results will be reported descriptively, both at individual patient level (no identifying data will be displayed) and in aggregate according to cohort.
Preliminary aggregate results from this cohort may be used for future more definitive studies assessing AT-01 in systemic amyloidosis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 26644 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 26645 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 42684 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 42685 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 316571 0
Commercial sector/Industry
Name [1] 316571 0
Attralus Inc
Country [1] 316571 0
United States of America
Funding source category [2] 316677 0
Charities/Societies/Foundations
Name [2] 316677 0
Princess Alexandra Research Foundation
Country [2] 316677 0
Australia
Funding source category [3] 316678 0
Government body
Name [3] 316678 0
Metro South Health
Country [3] 316678 0
Australia
Primary sponsor type
Government body
Name
Metro South Health
Address
Country
Australia
Secondary sponsor category [1] 318867 0
None
Name [1] 318867 0
Address [1] 318867 0
Country [1] 318867 0
Other collaborator category [1] 283073 0
Government body
Name [1] 283073 0
Olivia Newton John Cancer Research Institute
Address [1] 283073 0
Country [1] 283073 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315358 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 315358 0
Ethics committee country [1] 315358 0
Australia
Date submitted for ethics approval [1] 315358 0
16/03/2023
Approval date [1] 315358 0
03/07/2023
Ethics approval number [1] 315358 0
94901

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

Contacts
Principal investigator
Name 134450 0
Prof Peter Mollee
Address 134450 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, Queensland, 4102
Country 134450 0
Australia
Phone 134450 0
+61 0731766739
Fax 134450 0
Email 134450 0
[email protected]
Contact person for public queries
Name 134451 0
Peter Mollee
Address 134451 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, Queensland, 4102
Country 134451 0
Australia
Phone 134451 0
+61 0731766739
Fax 134451 0
Email 134451 0
[email protected]
Contact person for scientific queries
Name 134452 0
Peter Mollee
Address 134452 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, Queensland, 4102
Country 134452 0
Australia
Phone 134452 0
+61 0731766739
Fax 134452 0
Email 134452 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor and Primary Investigator.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the individual participant data collected during the trial, after de-identification with appropriate HREC approval.

What types of analyses could be done with individual participant data?
• To achieve the aims in the approved proposal.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date determined at this stage.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Obtained via contacting Principal Investigator email: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.