18F-FAPI PET in the Diagnosis of Liver Fibrosis

NCT ID: NCT05262647

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-12

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Fibrosis FAP Positron Emission Tomography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

18F-FAPI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guangjie Yang, PhD

Role: STUDY_CHAIR

The affiliated hostpital of Qingdao University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Guangjie Yang, PhD

Role: CONTACT

+86 053282913399

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Guangjie Yang, PhD

Role: primary

+86 17853297979

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QYFYWZLL26714

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Methods to Detect Liver Fibrosis
NCT03027700 TERMINATED NA
MRI to Measure Liver Fat Content
NCT00594412 COMPLETED NA
CT Liver Fat Fraction Quantification
NCT05676177 ENROLLING_BY_INVITATION NA