Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001078640
Ethics application status
Approved
Date submitted
18/09/2023
Date registered
10/10/2023
Date last updated
10/10/2023
Date data sharing statement initially provided
10/10/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study of fibroblast activation factor expression in recurrent/progressive pancreatic cancer and mesothelioma using [68Ga]Ga-Fibroblast Activation Protein Inhibitor (FAPI) -46 PET imaging.
Scientific title
Pilot study of fibroblast activation factor expression in recurrent/progressive pancreatic cancer and mesothelioma using [68Ga]Ga-FAPI-46 PET imaging.
Secondary ID [1] 310637 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mesothelioma 331521 0
pancreatic cancer 331522 0
Condition category
Condition code
Cancer 328255 328255 0 0
Lung - Mesothelioma
Cancer 328256 328256 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the study will undergo a single, additional PET/CT scan above their standard of care treatment. The [68Ga]Ga-FAPI-46 PET/CT will be performed at the Sir Charles Gairdner Hospital Department of Nuclear Medicine within 1 week +/- 2 days of the initial [18F]FDG scan under the supervision of a Nuclear Medicine consultant. Administered activity of [68Ga]Ga-FAPI-46 will be 185MBq +/- 10%. Post tracer administration there will be a rest period for tracer uptake of up to 3 hours before PET imaging is performed. The time in the scanner is around 30 minutes and the total time required for this visit will be up to 4 hours
Intervention code [1] 327039 0
Diagnosis / Prognosis
Comparator / control treatment
[18F]-FDG PET/CT scans are standard of care. The scans will be performed clinically with the patient referred by the treating clinician in the standard referral pathway. Images will be acquired as per current standard processes, [18F]-FDG will be produced onsite in the cyclotron/RAPID Laboratories facility using standard production methods and modules. The dose of [18F]-FDG administered is based on Body Mass Index and between 250 - 350MBq for an adult. Post tracer administration there is a rest period for tracer uptake of 1 hour before PET imaging is performed for 20 - 30 mins. The total time required for this visit will be 2 - 3 hours. The acquisition of the [68Ga]Ga-FAPI-46 PET scan and the [18F] FDG-PET scans are to be completed on separate calendar days,
Control group
Active

Outcomes
Primary outcome [1] 336119 0
Expression of fibroblast activation protein in advanced pancreatic cancer and mesothelioma will be assessed on PET imaging.
Timepoint [1] 336119 0
Single imaging timepoint
Primary outcome [2] 336120 0
Fibroblast activation protein expression in tumour using [68Ga]Ga-FAPI-46 PET will be compared to [18F]FDG tumour activity
Timepoint [2] 336120 0
Single imaging timepoint
Secondary outcome [1] 426888 0
[68Ga]Ga-FAPI-46 will be assessed for suitability for a subsequent theranostics application
Timepoint [1] 426888 0
Single imaging timepoint

Eligibility
Key inclusion criteria
1. Diagnosed with: pancreatic cancer which is locally advanced or recurrent/progressive disease or malignant pleural mesothelioma at initial diagnosis or suspected disease progression.
2. Referred for a clinical [18F]FDG PET/CT scan.
3. Male and females greater than 18 years old.
4. Able to provide informed consent and undergo study procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently receiving treatment for pancreatic cancer or mesothelioma (including chemotherapy, radiotherapy or immunotherapy)
2. Pregnant at the time of PET scans
3. Unable to provide informed consent
4. Unable to undergo study procedures
5. Other active neoplastic disease

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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/08/2023
Date of last participant enrolment
Anticipated
23/08/2024
Actual
Date of last data collection
Anticipated
23/08/2024
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25553 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 41375 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 314854 0
Charities/Societies/Foundations
Name [1] 314854 0
Charlies Foundation for Research
Country [1] 314854 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner and Osborne Park Health Care Group
Address
Hospital Avenue, Nedlands Western Australia 6009
Country
Australia
Secondary sponsor category [1] 316844 0
None
Name [1] 316844 0
Address [1] 316844 0
Country [1] 316844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313853 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 313853 0
Hospital Avenue, Nedlands 6009, Western Australia
Ethics committee country [1] 313853 0
Australia
Date submitted for ethics approval [1] 313853 0
03/08/2021
Approval date [1] 313853 0
10/11/2021
Ethics approval number [1] 313853 0

Summary
Brief summary
This study aims to investigate the potential of a new PET imaging tracer, [68Ga]Ga-FAPI-04 (Fibroblast Activation Protein Inhibitor), for imaging pancreatic cancer and
malignant pleural mesothelioma (lung cancer) compared to the current standard imaging tracer [18F]FDG.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with either pancreatic cancer which is locally advanced or recurrent/progressive or malignant pleural mesothelioma and have been referred by your treating doctor to have a fluorodeoxyglucose (FDG)-positron emission tomography (PET) scan (or FDG PET scan).

Study details
All participants who choose to enrol in this study will be asked to undergo one PET scan with the [68Ga]Ga-FAPI tracer. This involves one additional visit to hospital within one week of your FDG PET scan. At this visit, a needle is inserted into a hand or arm vein and a small amount of the radioactive [68Ga]Ga-FAPI is injected. Participants will rest for up to 3 hours while the [68Ga]Ga-FAPI travels through the blood stream and is taken up by pancreatic cancer cells or mesothelioma cells before being positioned on the bed of the PET scanner. The time in the scanner is around 30 minutes and the total time required for this visit will be up to 4 hours. This additional PET scan is for research only and will not be used to change your treatment. Over the next 12 months, your medical records will be accessed to follow up your clinical treatment and any other imaging performed. This will not involve any additional appointments for you.

It is hoped this pilot study will confirm that advanced pancreatic cancer and mesothelioma cancer cells express Fibroblast Activation (FA-protein) on the cell surface and can be imaged with [68Ga]Ga-FAPI PET imaging. If so, future research will examine using the FAPI agent with a different radioactive tag which could kill the cancer cells instead of imaging them.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129562 0
Dr Laurence Morandeau
Address 129562 0
Department of Medical Technology and Physics, Sir Charles Gairdner Hospital. Hospital Avenue, Nedlands 6009, Western Australia
Country 129562 0
Australia
Phone 129562 0
+61864572322
Fax 129562 0
Email 129562 0
Laurence.Morandeau@health.wa.gov.au
Contact person for public queries
Name 129563 0
Dr Laurence Morandeau
Address 129563 0
Department of Medical Technology and Physics, Sir Charles Gairdner Hospital. Hospital Avenue, Nedlands 6009, Western Australia
Country 129563 0
Australia
Phone 129563 0
+61864572322
Fax 129563 0
Email 129563 0
Laurence.Morandeau@health.wa.gov.au
Contact person for scientific queries
Name 129564 0
Dr Laurence Morandeau
Address 129564 0
Department of Medical Technology and Physics, Sir Charles Gairdner Hospital. Hospital Avenue, Nedlands 6009, Western Australia
Country 129564 0
Australia
Phone 129564 0
+61864572322
Fax 129564 0
Email 129564 0
Laurence.Morandeau@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.