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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
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
Secondary ID [1] 312395 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic cancer 334216 0
Condition category
Condition code
Cancer 330881 330881 0 0
Lung - Non small cell
Cancer 330882 330882 0 0
Lung - Mesothelioma
Cancer 330883 330883 0 0
Liver
Cancer 330884 330884 0 0
Head and neck

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 328909 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338636 0
Response rates
Timepoint [1] 338636 0
Response assessment with standard of care scans 3 months after commencing treatment
Secondary outcome [1] 436752 0
Progression Free Survival
Timepoint [1] 436752 0
1 year and 2 years after commencing treatment
Secondary outcome [2] 437672 0
Overall survival
Timepoint [2] 437672 0
1 year and 2 years after commencing treatment

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have commenced treatment on immunotherapy
2. Patients unable to provide informed consent

Study design
Purpose of the study
Treatment
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/06/2024
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
28/02/2027
Actual
Sample size
Target
40
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26731 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 42778 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 316804 0
Hospital
Name [1] 316804 0
Fiona Stanley Hospital
Country [1] 316804 0
Australia
Primary sponsor type
Hospital
Name
Medical Oncology Department Fiona Stanley Hospital
Address
Country
Australia
Secondary sponsor category [1] 319042 0
None
Name [1] 319042 0
Address [1] 319042 0
Country [1] 319042 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315574 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315574 0
https://smhs.health.wa.gov.au/Our-research/For-researchers
Ethics committee country [1] 315574 0
Australia
Date submitted for ethics approval [1] 315574 0
01/11/2023
Approval date [1] 315574 0
11/01/2024
Ethics approval number [1] 315574 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135122 0
Dr Hsing Hwa Lee
Address 135122 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch WA 6150
Country 135122 0
Australia
Phone 135122 0
+61 861522222
Fax 135122 0
Email 135122 0
[email protected]
Contact person for public queries
Name 135123 0
Hsing Hwa Lee
Address 135123 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch WA 6150
Country 135123 0
Australia
Phone 135123 0
+61861522222
Fax 135123 0
Email 135123 0
[email protected]
Contact person for scientific queries
Name 135124 0
Hsing Hwa Lee
Address 135124 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch WA 6150
Country 135124 0
Australia
Phone 135124 0
+61861522222
Fax 135124 0
Email 135124 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


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.