18F-FAPI PET Imaging in Pancreatic Adenocarcinoma

Study Overview
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Brief Summary
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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
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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).

Official Title
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18F-FAPI PET/CT and 18F-FDG PET/CT in Patients With Pancreatic Adenocarcinoma : A Prospective, Single-Center, Comparative Study

Conditions
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18F-FAPI, 18F-FDG, Pancreas Adenocarcinoma, Diagnosis, Staging

Intervention / Treatment
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* Drug: 18F-FAPI
* Drug: 18F-FDG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan | Drug: 18F-FAPI<br>* Intravenous injection of one dosage of 18F-FAPI.<br>* Other names: (18)F-FAPI;Drug: 18F-FDG<br>* Intravenous injection of one dosage of 18F-FDG.<br>* Other names: (18)F-FDG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 |