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NCT05262647 Clinical Trial

18F-FAPI PET in the Diagnosis of Liver Fibrosis

Liver Fibrosis Clinical Trial

Official title:
A Prospective Study for Effectiveness of 18F-FAPI PET in the Diagnosis of Liver Fibrosis: Comparison With Liver Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05262647
Other study ID # QYFYWZLL26714
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 12, 2021
Est. completion date December 1, 2022

Study information
Verified date February 2022
Source The Affiliated Hospital of Qingdao University
Contact Guangjie Yang, PhD
Phone +86 053282913399
Email ygj_2815@qq.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 18F-FAPI
Patients with chronic liver disease underwent 18F-FAPI-04 PET/CT and percutaneous liver biopsy.

Locations
Country Name City State
China The Affiliated Hospital of Qingdao University Qingdao Shandong

Sponsors (1)
Lead Sponsor Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 18F-FAPI PET in the Diagnosis of Liver Fibrosis 18F-FAPI as a PET-CT biomarker to Liver Fibrosis 12.01.2021 to12.01.2022
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