18F-FAPI PET Imaging in Pancreatic Adenocarcinoma

Not Applicable

Completed

• Conditions: Staging; Pancreas Adenocarcinoma; Diagnosis; 18F-FAPI; 18F-FDG
• Interventions: Drug: 18F-FAPI; Drug: 18F-FDG

• Registration Number: NCT05884463
• Lead Sponsor: Zhejiang University

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 Timeline

• Study Start: 2021-04-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-05
• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study First Posted: 2023-06-01
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	18F-FAPI	Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan
Experimental	18F-FDG	Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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 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

Trial Locations

Locations (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China