18F-FAPI PET in the Diagnosis of Liver Fibrosis

• Conditions: Positron Emission Tomography; FAP; Liver Fibrosis

• Registration Number: NCT05262647
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

It is an open label observation clinical trial, all participants are chronic liver disease. The investigators deem to make a novel evaluate criteria to hepatic fibrosis. The point of the clinical trial is to evaluate the novel biomaker 18F-FAPI-04 by PET-CT scan in the evaluation of the hepatic fibrosis.

Detailed Description

Participants are with clinically confirmed chronic liver disease,including chronic viral hepatitis, autoimmune hepatitis, liver disease after liver transplantation, nonalcoholic fatty liver disease, alcoholic hepatitis, primary biliary cholangitis, primary sclerosing cholangitis and congestive hepatopathy etc.

Participants are without liver tumor and other liver disease besides liver fibrosis Participants has no history of malignant tumors Participants agree to performe FAPI PET and liver biopsy

Study Timeline

• Study Start: 2021-12-12
• Study First Submitted: 2021-12-15
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-21
• Last Update Submitted: 2022-02-21
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinically confirmed chronic liver disease,including chronic viral hepatitis, autoimmune hepatitis, liver disease after liver transplantation, nonalcoholic fatty liver disease, alcoholic hepatitis, primary biliary cholangitis, primary sclerosing cholangitis and congestive hepatopathy etc.
• Without liver tumor and other liver disease besides liver fibrosis
• No history of malignant tumors
• Agree to performe FAPI PET and liver biopsy

Exclusion Criteria

• Pregnancy
• With anti-hepatic fibrosis treatment in 6 months
• With contraindications to percutaneous liver biopsy,for such as uncooperative patient, severe coagulopathy, extrahepatic biliary obstruction,etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
18F-FAPI PET in the Diagnosis of Liver Fibrosis	12.01.2021 to12.01.2022	18F-FAPI as a PET-CT biomarker to Liver Fibrosis

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China