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Clinical Trials/ACTRN12621000935831
ACTRN12621000935831
Recruiting
N/A

A pilot study to evaluate the diagnostic and therapeutic applications of FAPI-PET in pancreatic cancer.

Royal Brisbane & Women's Hospital0 sites62 target enrollmentJuly 16, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Royal Brisbane & Women's Hospital
Enrollment
62
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 16, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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.

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.

Outcomes

Primary Outcomes

Not specified

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