Diagnosis Clinical Trial
Official title:
18F-FAPI PET/CT and 18F-FDG PET/CT in Patients With Pancreatic Adenocarcinoma : A Prospective, Single-Center, Comparative Study
Verified date | May 2023 |
Source | Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | February 28, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | the First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic value | Sensitivity and Specificity of 18F-FAPI PET/CT for diagnosis and staging in comparison with 18F-FDG PET/CT | 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT) | |
Primary | Maximum standardized uptake value | SUVmax of 18F-FAPI PET/CT for lesions in comparison with 18F-FDG PET/CT | 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT) | |
Secondary | Diagnostic efficacy for primary lesions | Sensitivity, specificity, accuracy of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT | 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT) | |
Secondary | SUVmax for primary lesions | SUVmax of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT | 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT) | |
Secondary | SUVmax for lymph node | SUVmax of 18F-FAPI PET/CT for lymph node in comparison with 18F-FDG PET/CT | 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT) | |
Secondary | SUVmax for distant metastasis | SUVmax of 18F-FAPI PET/CT for distant metastasis in comparison with 18F-FDG PET/CT | 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT) | |
Secondary | Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response | The correlation of SUVmax and treatment response | at least 2 months after treatment |
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