Clinical utility of [68Ga] fibroblast activation protein inhibitor (FAPI) positron emission tomography and computed tomography (PET/CT) in patients with potentially resectable pancreatic ductal adenocarcinoma (PDAC).
- Conditions
- pancreatic cancerCancer - Pancreatic
- Registration Number
- ACTRN12623000518662
- Lead Sponsor
- Metro South Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic efficacy for pancreatic ductal adenocarcinoma<br>Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of 68Ga-FAPI PET/CT for pancreatic cancer in comparison with 18F-FDG PET/CT pre- and post- chemotherapy[ 1 week and 12 weeks after enrolment ];Maximum standardized uptake value (SUVmax) <br>SUVmax of 68Ga-FAPI PET/CT in patients with pancreatic cancer in comparison with 18F-FDG PET/CT pre- and post - chemotherapy [ 1 week and 12 weeks after enrolment]
- Secondary Outcome Measures
Name Time Method Sensitivity of FAPI PET/CT SUVmax assessed by correlation between the expression of fibroblast activation protein (FAP) in pre-and post treatment tissue specimens and 68Ga-FAPI uptake.<br>Analysing the correlation between the SUVmax of 68Ga-FAPI in pancreatic lesions, with FAP expression in pre and post treatment tissue specimens.[ 16 weeks post enrolment ];Percentage of fibroblast activation protein (FAP) expression<br>Percentage of FAP expression in the pre-treatment biopsy specimen and the post chemotherapy resected specimen[ 16 weeks after enrolment ]