Applicability of Positron Emission Tomography using Gallium-68 labelled Fibroblast Activating Protein Inhibitor for the diagnosis, staging and treatment of pancreatic cancer.

Not Applicable

Recruiting

• Conditions: Cancer - Pancreatic; Pancreatic Cancer

• Registration Number: ACTRN12621000935831
• Lead Sponsor: Royal Brisbane & Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-16
• Last Update Posted: 5 June 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

This will be a dual centre, prospective, single arm study. We aim to recruit up to 12 patients in this initial phase of the 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified