18F-FAPI PET in the Diagnosis of Liver Fibrosis | NCT05262647

Studies
18F-FAPI PET in the Diagnosis of Liver Fibrosis

NCT05262647

Sponsor

The Affiliated Hospital of Qingdao University

Status

Unknown status

Last Update Posted

Mar 2, 2022Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Liver Fibrosis
FAP
Positron Emission Tomography

Interventions

18F-FAPI

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2021Actual

Primary Completion Date

Dec 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Dec 15, 2021

First Submission Date that Met QC Criteria

Feb 21, 2022

First Posted Date

Mar 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2022

Last Update Posted Date

Mar 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FAPI	Diagnostic Test	Patients with chronic liver disease underwent 18F-FAPI-04 PET/CT and percutaneous liver biopsy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients has been pathological diagnosis as Liver Fibrosis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guangjie Yang, PhD	Contact	+86 053282913399		ygj_2815@qq.com

Overall Officials

Name	Affiliation	Role
Guangjie Yang, PhD	The affiliated hostpital of Qingdao University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Affiliated Hospital of Qingdao University	Recruiting	Qingdao	Shandong	266000	China

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

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