None listed
Conditions
Brief summary
This study aims to assess the usefulness of a new cancer imaging technique, [68Ga]-labelled fibroblast activation protein inhibitor (FAPI) positron emission tomography and computed tomography (PET/CT) compared to the current standard [18F] fluorodeoxyglucose (FDG) PET/CT imaging for people with potentially resectable pancreatic cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with early stage pancreatic cancer that is suitable for surgical removal and you have not yet started chemotherapy treatment for your cancer. Study details All participants who choose to enrol in this study will undergo 2 FDG PET/CT scans as part of routine care as well as 2 FAPI PET/CT scans. FAPI PET/CT scans are in addition to the standard of care imaging. Participants will firstly have a standard FDG-PET/CT scan. Participants will then undergo the new FAPI PET/CT scan within one week of the first scan. Both scans will involve injection of a dye prior to the scan, each scan is anticipated to take 1h30mins. Participants will then undergo their scheduled chemotherapy over 8 weeks. After completing their chemotherapy, participants will be asked to complete the final two scans following the same procedures as the first two scans. Should the participant proceed to surgery, the resection specimens will undergo routine histological evaluation as per standard guidelines. After diagnostic requirements have been completed, IHC for FAP expression will be performed. This is the end of the clinical trial and participants will continue care with their regular Medical Oncologist and Hepatobiliary Surgeon. It is hoped this research will demonstrate whether a new imaging procedure is able to better identify tumour tissue borders in people with potentially resectable pancreatic cancer. If the new imaging procedure is successful, it may assist doctors to prescribe more personalised treatment options to pancreatic cancer patients that may increase their treatment success.
Interventions
This study is evaluating a new radio-isotype, [68Ga] FAPI, thought to be more accurate than [18F] Fluorodeoxyglucose [FDG] isotype in staging of patients with pancreatic cancer.
All patients fulfilling inclusion criteria will be referred for PET/CT scanning as arranged by the coordinating investigator. Patients will first undergo [18F] FDG PET as part of pre-treatment workup, followed by [68 Ga] FAPI PET/CT, within approximately seven days.
[68 Ga] FAPI PET/CT Imaging Protocol:
The specific
This study is evaluating a new radio-isotype, [68Ga] FAPI, thought to be more accurate than [18F] Fluorodeoxyglucose [FDG] isotype in staging of patients with pancreatic cancer. All patients fulfilling inclusion criteria will be referred for PET/CT scanning as arranged by the coordinating investigator. Patients will first undergo [18F] FDG PET as part of pre-treatment workup, followed by [68 Ga] FAPI PET/CT, within approximately seven days. [68 Ga] FAPI PET/CT Imaging Protocol: The specific radio-isotype used is the [68 Ga]-FAPI-46 variant, and the dose is calculated according to the patient’s weight, 1.8–2.2 MBq/kg. Static PET/CT imaging will be performed using the Siemens PET/CT scanner 60 minutes after intravenous injection and includes the base of the skull to the upper thighs. A qualified nuclear medicine physicist will conduct the procedure and a Nuclear Medicine Radiologist will report the results of the scan. The entire duration of the scan is approximately 1h30mins. Patients will then receive standard of care chemotherapy, and approximately 28 days after the patient has completed their fourth cycle of chemotherapy, patients will repeat a [18F] FDG PET/CT standard of care imaging, followed by a [68 Ga] FAPI PET/CT within approximately 7 days. Following repeat PET/CT scanning, the patient’s response to chemotherapy will be discussed at the Hepatobiliary (HPB) multidisciplinary meeting and and the patient will be evaluated for surgery. If still deemed resectable, the patient will proceed to surgery. Resection specimens will undergo routine histological evaluation as per standard guidelines. After diagnostic requirements have been completed, IHC for FAP expression will be performed. This is the end of the patient's participation in the trial. Patients will continue routine care and follow up with their regular Medical Oncologist and HPB Surgeon.
Sponsors
Metro South Health
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Age greater than or equal to 18years - Able to give informed consent - Histological specimen from the primary pancreatic lesion confirming the diagnosis of PDAC. - Patients need to have either a resectable or borderline resectable pancreatic lesion after imaging review at the HPB multidisciplinary (MDT) meeting - No metastatic disease - Eastern Cooperative Oncology Group performance status of less than or equal to 1 - No contraindications to neoadjuvant chemotherapy.
Exclusion criteria
- Patients not medically fit for peri-operative chemotherapy with FOLFIRINOX or surgery - Patients with known or suspected metastatic disease - Pregnant or breastfeeding patients (if a female patient is pre-menopausal, she will require a negative urine pregnancy test prior to enrolment) - Patients with allergies to or contraindications to [68 Ga] FAPI or [18F] FDG tracer - Patients who have had surgery or chemotherapy prior to 1st PET/CT imaging.
Outcome results
None listed