18F-FAPI PET in the Diagnosis of Liver Fibrosis

February 21, 2022 updated by: The Affiliated Hospital of Qingdao University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Guangjie Yang, PhD
  • Phone Number: +86 053282913399
  • Email: ygj_2815@qq.com

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients has been pathological diagnosis as Liver Fibrosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
18F-FAPI PET in the Diagnosis of Liver Fibrosis
Time Frame: 12.01.2021 to12.01.2022
18F-FAPI as a PET-CT biomarker to Liver Fibrosis
12.01.2021 to12.01.2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Qingdao University

Investigators

  • Study Chair: Guangjie Yang, PhD, The affiliated hostpital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QYFYWZLL26714

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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