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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• 18F-FDG
• Adenocarcinoma
• Diagnosis
• Pancreas Adenocarcinoma
• Staging

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