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NCT05884463 Clinical Trial

18F-FAPI PET Imaging in Pancreatic Adenocarcinoma

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05884463
Other study ID # FAPIPDAC01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date February 28, 2023

Study information
Verified date May 2023
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 18F-FAPI
Intravenous injection of one dosage of 18F-FAPI.
• 18F-FDG
Intravenous injection of one dosage of 18F-FDG.

Locations
Country Name City State
China the First Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
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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