18F-FAPI, 18F-FDG, Pancreas Adenocarcinoma, Diagnosis, Staging
Conditions
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).
Interventions
DRUG18F-FAPI
Intravenous injection of one dosage of 18F-FAPI.
DRUG18F-FDG
Intravenous injection of one dosage of 18F-FDG.
Sponsors
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic value | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| SUVmax for lymph node | 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT) | SUVmax of 18F-FAPI PET/CT for lymph node in comparison with 18F-FDG PET/CT |
| Diagnostic efficacy for primary lesions | 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT) | Sensitivity, specificity, accuracy of 18F-FAPI PET/CT for primary lesions in comparison with 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 | The correlation of SUVmax and treatment response |
| SUVmax for distant metastasis | 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT) | SUVmax of 18F-FAPI PET/CT for distant metastasis in comparison with 18F-FDG PET/CT |
| SUVmax for primary lesions | 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT) | SUVmax of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT |
Countries
China
Outcome results
None listed