None listed
Conditions
Brief summary
The aim of this study is to assess the feasibility, efficacy, and safety of a new type of cancer imaging called gallium-68 fibroblast activation protein inhibitor (68Ga-FAPI) positron emission tomography/computed tomography (PET/CT), compared to the standard of care cancer imaging called 18F-fluorodeoxyglucose (18F-FDG) PET/CT, for the staging/restaging (i.e. determining how much cancer is in the body and where it is) of pancreatic cancer. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older, have histologically or cytologically confirmed pancreatic cancer, and are under consideration for surgical resection by a Wesley hepatopancreaticobiliary (HPB) surgeon. Study details All participants will undergo a FDG PET/CT scan at I-MED Radiology, The Wesley Hospital, as part of standard care. This will involve the injection of 2.5MBq/kg + 75MBq FDG tracer intravenously, followed by the PET/CT scan 60 minutes post tracer administration +/- 10minutes, and will take approximately 30 minutes to complete. Within 1-7 days of the FDG PET/CT scan, a FAPI PET/CT scan will be performed at I-MED Radiology, The Wesley Hospital. This will involve the injection of 2.5MBq/kg FAPI tracer intravenously, followed by the PET/CT scan 60 minutes +/- 10 minutes later, and will take approximately 30 minutes to complete. The two scans will be compared for their ability to detect pancreatic cancer lesions and the effect of this on staging or restaging of the disease. Participants will also be monitored for side effects following injection of both tracers to determine the safety of each technique. In conducting this study, we hope to provide proof-of-principle that FAPI PET/CT provides a clinically useful imaging modality for the staging/restaging of pancreatic cancer at The Wesley Hospital.
Interventions
This study is a prospective, non-randomised, non-blinded feasibility study comparing two PET/CT tracers. This study will involve ten patients, who will each undergo both a FDG PET/CT scan and a FAPI PET/CT scan. The patients will each have a diagnosis of a pancreatic cancer and be undergoing PET/CT imaging for staging/restaging for the purposes of being considered for surgical resection. Patients in this scenario would routinely undergo a FDG PET/CT scan for the purposes of staging/restaging, th
This study is a prospective, non-randomised, non-blinded feasibility study comparing two PET/CT tracers. This study will involve ten patients, who will each undergo both a FDG PET/CT scan and a FAPI PET/CT scan. The patients will each have a diagnosis of a pancreatic cancer and be undergoing PET/CT imaging for staging/restaging for the purposes of being considered for surgical resection. Patients in this scenario would routinely undergo a FDG PET/CT scan for the purposes of staging/restaging, thus participation in this study requires one intervention outside of standard care (the FAPI PET/CT scan). A FDG PET/CT scan will be performed at I-MED Radiology, The Wesley Hospital, and reported by one of the nuclear medicine radiologists involved in this study, as standard care. The approximate duration required for completion of each FDG scan is 2hrs. 2.5MBq/kg +75 of FDG tracer will be administered to each patient through intravenous cannulation. FDG tracer will be administered 60minutes prior to the PET/CT scan. Within 1-7 days of the FDG PET/CT scan, a FAPI PET/CT scan will be performed at I-MED Radiology, The Wesley Hospital, and reported by the same nuclear medicine radiologist. The approximate duration required for completion of each FAPI scan is 2hrs. 2.5MBq/kg of FAPI tracer will be administered to each patient through intravenous cannulation. FAPI tracer will be administered 60minutes prior to the PET/CT scan. Doses are measured in a dose calibrator and documented on patient paperwork and the administration system. The dose calibrator is quality tested daily. The dose will be administered following a flush of 10mls of saline to test the patency of the cannula & followed by 20mls of saline to ensure the dose has gone through. Pre- and post-measurements of syringes will be made. Once each PET/CT scan has been individually assessed, the nuclear medicine radiologist who has reported the scans will directly compare the two scans. The reporting radiologist and the patient’s Hepato-Pancreato-Biliary (HPB) surgeon will discuss the results of the PET/CT scans. Patients will continue under the care of their HPB surgeon and treating medical team, with no further study involvement.
Sponsors
I-MED Radiology Network
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria • Minimum of 18 years of age • Histologically or cytologically confirmed pancreatic cancer • Under consideration for surgical resection by a Wesley HPB surgeon • No treatment with chemotherapy, external beam radiation, immunotherapy and/or angiogenesis inhibitors for up to four weeks prior to study PET/CT scans • Adequate renal function (A patient’s eGFR needs to be greater than 35mL/min/1.73m2 to receive CT contrast). • Ability to understand and willingness to sign a written informed consent document • Willing and able to comply with the two required PET/CT scans This patient group has been selected as they represent a group in which current imaging methods for staging/restaging presents an unmet diagnostic challenge.
Exclusion criteria
Exclusion criteria • Pancreatic disease too advanced for surgical resection to be considered standard care • Concurrent malignancies, except non-melanoma skin cancers • Pregnant or breast feeding • Participation would delay imminent conventional treatment • History of allergic reactions attributed to compounds of similar chemical or biologic composition to FAPI, FDG or intravenous iodinated contrast media • Involvement in a clinical trial with an investigational agent which may reasonably interfere with the PET/CT imaging • Uncontrolled intercurrent illness which may reasonably interfere with PET/CT imaging, including, but not limited to, active infection or inflammatory process
Outcome results
None listed