18F-FAPI PET in the Diagnosis of Liver Fibrosis

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05262647

Enrollment

Registered

2022-03-02

Start date

2021-12-12

Completion date

2022-12-01

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Fibrosis, FAP, Positron Emission Tomography

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

Interventions

DIAGNOSTIC_TEST18F-FAPI

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactGuangjie Yang, PhD

ygj_2815@qq.com+86 053282913399

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026