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Trial registered on ANZCTR
Registration number
ACTRN12624000906550
Ethics application status
Approved
Date submitted
25/06/2024
Date registered
25/07/2024
Date last updated
29/08/2024
Date data sharing statement initially provided
25/07/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Role of Novel Imaging in Prognosis and Response to Immunotherapy in Advanced Cancers
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Scientific title
The Role of FAPI-46 (Fibroblast activation protein inhibitor) PET (positron emission tomography) Imaging in Prognosis and Response to Immunotherapy in Metastatic Cancers
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Secondary ID [1]
312395
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic cancer
334216
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Condition category
Condition code
Cancer
330881
330881
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0
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Lung - Non small cell
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Cancer
330882
330882
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0
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Lung - Mesothelioma
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Cancer
330883
330883
0
0
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Liver
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Cancer
330884
330884
0
0
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
1. All patients will do one baseline FAPI-PET scan only to assess their Fibroblast Activation Protein (FAP) expression on imaging and we will also test their FAP immunohistochemistry in their pre-existing tissue biopsy. The scan can take up to 1 hour and the contrast administed is Ga68-FAPI46. This scan is done by the nuclear medicine department and will be reported by nuclear medicine physician.
2. We will correlate the FAP expression with patients clinical outcomes in terms of response, progression free survival and overall survival. Patients will undergo standard of care imaging and follow up . We plan to follow patients for up to 2 years post scan
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Intervention code [1]
328909
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
338636
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Response rates
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Assessment method [1]
338636
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Response assessment based on standard of care CT scans with RECIST or FDG-PET with PERCIST criteria.
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Timepoint [1]
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Response assessment with standard of care scans 3 months after commencing treatment
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Secondary outcome [1]
436752
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Progression Free Survival
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Assessment method [1]
436752
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progression free survival determined from medical records
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Timepoint [1]
436752
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1 year and 2 years after commencing treatment
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Secondary outcome [2]
437672
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Overall survival
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Assessment method [2]
437672
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Overall survival determined from medical records
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Timepoint [2]
437672
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1 year and 2 years after commencing treatment
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Eligibility
Key inclusion criteria
1. Age 18 years and above with prognosis more than 3 months and less than 2 years
2. Histologically confirmed metastatic head and neck squamous cell carcinoma, hepatocellular carcinomas, mesothelioma, non-small cell lung cancers planned for immunotherapy containing regimen only
3. At least one measurable lesion, defined by RECIST or PERCIST criteria
4. Patients who have had previous curative treatment or prior lines of chemotherapy without immunotherapy are allowed
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients who have commenced treatment on immunotherapy
2. Patients unable to provide informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
21/06/2024
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Date of last participant enrolment
Anticipated
28/02/2025
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Actual
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Date of last data collection
Anticipated
28/02/2027
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Actual
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Sample size
Target
40
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Accrual to date
4
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
26731
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
42778
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6150 - Murdoch
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Funding & Sponsors
Funding source category [1]
316804
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Hospital
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Name [1]
316804
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Fiona Stanley Hospital
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Address [1]
316804
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Country [1]
316804
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Australia
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Primary sponsor type
Hospital
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Name
Medical Oncology Department Fiona Stanley Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319042
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None
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Name [1]
319042
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Address [1]
319042
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Country [1]
319042
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315574
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
315574
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https://smhs.health.wa.gov.au/Our-research/For-researchers
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Ethics committee country [1]
315574
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Australia
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Date submitted for ethics approval [1]
315574
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01/11/2023
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Approval date [1]
315574
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11/01/2024
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Ethics approval number [1]
315574
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Summary
Brief summary
This study will evaluate the role of FAPI-46 (Fibroblast activation protein inhibitor) PET (positron emission tomography) imaging in prognosis and response to immunotherapy in metastatic cancers Who is it for? You may be eligible to join this study if you are aged 18 years and above, have histologically confirmed metastatic head and neck squamous cell carcinoma, hepatocellular carcinomas, mesothelioma, non-small cell lung cancers and planned for immunotherapy containing regimen only. Study details All participants in this study will have FAPI-46 PET imaging performed before immunotherapy treatment. We will also assess FAP expression via immunohistochemistry on the available tissue samples that were already taken for diagnosis. Correlation of FAP expression in tumour samples via immunohistochemistry and FAP expression on imaging will be assessed. This research will help provide insight in the role of FAPI-46 PET scan and FAP in predicting prognosis and could be a stepping stone for future applications in potential targeted treatment and theranostics.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
135122
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Dr Hsing Hwa Lee
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Address
135122
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Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch WA 6150
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Country
135122
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Australia
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Phone
135122
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+61 861522222
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Fax
135122
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Email
135122
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[email protected]
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Contact person for public queries
Name
135123
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Hsing Hwa Lee
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Address
135123
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Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch WA 6150
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Country
135123
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Australia
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Phone
135123
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+61861522222
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Fax
135123
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Email
135123
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[email protected]
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Contact person for scientific queries
Name
135124
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Hsing Hwa Lee
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Address
135124
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Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch WA 6150
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Country
135124
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Australia
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Phone
135124
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+61861522222
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Fax
135124
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Email
135124
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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