NCT05262647

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

December 15, 2021

Last Update Submit

February 21, 2022

Conditions

Liver FibrosisFAPPositron Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

18F-FAPIDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients has been pathological diagnosis as Liver Fibrosis

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guangjie Yang, PhD

    The affiliated hostpital of Qingdao University

    STUDY CHAIR

Central Study Contacts

Guangjie Yang, PhD

CONTACT

+86 053282913399ygj_2815@qq.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

March 2, 2022

Study Start

December 12, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

CN(1)