None listed
Conditions
Brief summary
This study aims to determine whether the new drug fibroblast activating protein inhibitor (FAPI) can be used to detect pancreatic cancer when tracked using positron emission tomography (PET) scan. Who is it for? You may be eligible for this study if you are aged 18 or over and have confirmed pancreatic cancer or a suspicious pancreatic mass, and have not commenced treatment. Study details All participants will undergo pre-treatment positron emission tomography (PET) scan using the novel PET tracer Fibroblast Activating Protein Inhibitor (FAPI). Absorption of the tracer on PET scan will be evaluated by a nuclear medicine physician as part of the research team. The results of this scan will only be shared with your treating doctor if there could be a change to your treatment as a result. Information from this study will help evaluate the applicability of FAPI-PET for diagnosing and detecting deposits of pancreatic cancer. The results will also help determine if FAPI can be used to carry targeted radiation therapy directly to cancerous tissue. Although this study will inform further research into such a treatment, no participants in this study will receive targeted radiation therapy via FAPI.
Interventions
Participants will attend the RBWH Nuclear Imaging Department, or the Herston Imaging Research Facility (HIRF) on the RBWH campus, to undergo FAPI-PET scan with superimposed low dose computed tomography (FAPI-PET/CT).
The procedure requires insertion of an intravenous (IV) line for injection of the tracer. The specific tracer to be used is Gallium-68-FAPI-46 at a dose of 250MBq. Participants will have three separate PET/CT scans on the same day following just one injection of the tracer:
1. 10 m
Participants will attend the RBWH Nuclear Imaging Department, or the Herston Imaging Research Facility (HIRF) on the RBWH campus, to undergo FAPI-PET scan with superimposed low dose computed tomography (FAPI-PET/CT). The procedure requires insertion of an intravenous (IV) line for injection of the tracer. The specific tracer to be used is Gallium-68-FAPI-46 at a dose of 250MBq. Participants will have three separate PET/CT scans on the same day following just one injection of the tracer: 1. 10 minutes following injection of tracer: Scan over pancreas only (about 15 minutes lying on the scanner bed). 2. 60 minutes following injection of tracer: Scan of head to upper thighs. (about 30 minutes lying on the scanner bed). 3. 180 minutes following injection of tracer: Scan over pancreas only. (about 15 minutes lying on the scanner bed). The above imaging protocol represents the maximum radiation exposure a participant can receive as part of this study. Provided the data obtained is contributory to study outcomes, certain participants may undergo fewer scanning sessions or have less body area scanned. The time commitment for taking part in this study is 4 hours at maximum. Each participant will attend HIRF for the FAPI-PET/CT imaging protocol only once. The scan will take place within 14 days of enrolment in the study, although preferably within 7 days. FAPI-PET/CT is to take place prior to delivery of any surgical or systemic therapy, and prior to direct biopsy of the primary tumour mass for patients without known metastatic disease. The scan will be administered by staff with relevant qualifications in PET imaging at the RBWH Nuclear Imaging department or HIRF. FAPI-PET/CT images will be interpreted by a qualified nuclear medicine physician. The results of FAPI-PET/CT will be relayed to the treating clinician only if there could be a change to management as a result. Such cases will be re-discussed at the relevant multi-disciplinary team (MDT) meeting, and change to the treatment plan as a result will only occur if metastatic lesions are confirmed on biopsy or other established imaging techniques. See "study design" for further details. Participants will be followed up as usual by their treating clinician according to usual protocols. The researchers will collect information obtained at clinical follow up, as well as results of FAPI-PET/CT to evaluate study outcomes. If their pancreatic lesion undergoes surgical resection or biopsy, consenting participants will have excess tissue samples sent to the Translational Research Institute to undergo additional analysis. More specifically, this will involve immunohistochemistry to quantify expression of Fibroblast Activating Protein (FAP), which is the cellular target of FAPI-PET/CT.
Sponsors
Royal Brisbane & Women's Hospital
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
This will be a dual centre, prospective, single arm study. We aim to recruit up to 62 patients in this study. Key Inclusion criteria. Patients referred to any hepato-pancreato-biliary (HPB) surgeon or oncologist with admitting rights at the Royal Brisbane and Women’s Hospital (RBWH) and Princess Alexandra Hospital (PAH) will be considered for inclusion. Patients will be recruited into 1 of 3 groups based on the following inclusion criteria: a. Patients with pancreatic cancer and metastases. Must satisfy the following: i. Histology / cytology specimen from primary or metastatic lesion highly suggestive of pancreatic or peri-ampullary adenocarcinoma. ii. Distant metastases diagnosed on conventional cross-sectional imaging. b. Patients with probable pancreatic cancer that is potentially resectable. Must satisfy the following: i. Solid or infiltrating mass arising from pancreatic parenchyma on cross sectional imaging or common bile duct brushings highly suggestive of pancreatic or peri-ampullary adenocarcinoma. ii. Has undergone cross sectional imaging of chest abdomen and pelvis without the diagnosis of metastases or local un-resectable features. iii. Has not undergone direct biopsy of the tumour mass prior to FAPI-PET/CT. c. c. Patients with a cystic pancreatic lesion without confirmed malignancy. Must satisfy the following: i. Cystic pancreatic lesion detected on cross sectional imaging or endoscopic ultrasound. ii. Patient exhibits at least one “worrisome feature” or “high-risk stigmata” according to Fukuoka guidelines: [Tanaka et al 2017: see below reference]. Additional Inclusion criteria. i. No known problems of peripheral intravenous access. ii. Able to provide informed, signed consent. iii. All women of childbearing age considered for the study must have a pregnancy test prior to enrolment. Reference: Tanaka, M., et al., Revisions of international consensus Fukuoka guidelines for the management of IPMN of the pancreas. Pancreatology, 2017. 17(5): p. 738-753.
Exclusion criteria
Exclusion criteria i. Aged under 18 years of age. ii. Administered a radioisotope within 5 half-lives prior to the intended scan. iii. Patients with allergies to the FAPI or FDG PET tracer. iv. Pregnant patients. v. Patients who have started chemotherapy or radiotherapy for their disease prior to FAPI-PET/CT. vi. Patients who have undergone surgery for their disease prior to FAPI-PET/CT. vii. Unable to lie flat to tolerate PET scanning. viii. Prior history of other malignancy within the last 2 years.
Outcome results
None listed