18F-FAPI PET/CT and 18F-FDG PET/CT in Patients With Pancreatic Adenocarcinoma : A Prospective, Single-Center, Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Diagnostic value
Study Overview
Brief Summary
To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare the results with those obtained using 18F-FDG PET/CT.
Detailed Description
Accurate diagnosis and staging are crucial for selecting treatment for patients with pancreatic ductal adenocarcinoma (PDAC). The desmoplastic responses associated with PDAC are often characterised by hypometabolism. Here we investigated 18F-fibroblast activation protein inhibitor (18F-FAPI-04) positron emission tomography/computed tomography (PET/CT) in evaluation of PDAC, and compared the findings with those obtained using (18F)-fluorodeoxyglucose (18F-FDG).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients who were suspected to have PDAC by radiological imaging patients who underwent paired 18F-FAPI-04 PET/CT and 18F-FDG PET/CT for metastasis screening, recurrence confirmation, or tumour staging patients who were willing to participate in clinical trials and signed an informed consent form.
Exclusion Criteria
- •patients with a history of severe contrast allergy pregnant patients patients who were not pathologically diagnosed as showing PDAC.
Arms & Interventions
Experimental
Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan
Intervention: 18F-FAPI (Drug)
Experimental
Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan
Intervention: 18F-FDG (Drug)
Outcomes
Primary Outcomes
Diagnostic value
Time Frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Sensitivity and Specificity of 18F-FAPI PET/CT for diagnosis and staging in comparison with 18F-FDG PET/CT
Maximum standardized uptake value
Time Frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax of 18F-FAPI PET/CT for lesions in comparison with 18F-FDG PET/CT
Secondary Outcomes
- Diagnostic efficacy for primary lesions(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))
- SUVmax for lymph node(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))
- SUVmax for distant metastasis(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))
- Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response(at least 2 months after treatment)
- SUVmax for primary lesions(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))
Investigators
TingBo Liang
Professor
Zhejiang University