None listed
Conditions
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.
Interventions
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 P
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
Sponsors
Sir Charles Gairdner and Osborne Park Health Care Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed