None listed
Conditions
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.
Interventions
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, progre
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
Sponsors
Medical Oncology Department Fiona Stanley Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
1. Patients who have commenced treatment on immunotherapy 2. Patients unable to provide informed consent
Outcome results
None listed