68Ga-FAPI PET/CT in Liver Fibrosis Patients

Liver Fibrosis Clinical Trial

— GFAPILF  

Official title:

Value of 68Ga-FAPI-04 PET/CT for Diagnosis and Prognostic Evaluation in Liver Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04533828
• Other study ID #: FAPILF
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2020
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Weibing Miao, M.D.
• Phone: 86-591-87981618
• Email: miaoweibing[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis and prognosis in liver fibrosis disease.

Description:

Subjects with liver fibrosis underwent 68Ga-FAPI-04 PET/CT scanning. Liver fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax). Subjects also received the conventional clinical assessment for liver fibrosis, such as transient elastography (TE) and blood biochemical indexes (BBI) testing. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-FAPI-04 PET/CT, TE and BBI were calculated and compared to evaluate the diagnostic efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• adult patients (aged 18 years or order)

• patients with suspected or new diagnosed or previously treated liver fibrosis (supporting evidence may include TE, BBI, MRI, CT and pathology report)

• patients who had scheduled 68Ga-FAPI-04 PET/CT scan

• patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee

Exclusion Criteria:

• patients without liver fibrosis lesions

• patients with pregnancy

• the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis
• Positron Emission Tomography

Intervention

Drug:
• 68Ga-FAPI-04
Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value (SUV)	Standardized uptake value (SUV) of 68Ga-FAPI-04 for each target lesion of subject or suspected liver fibrosis.	30 days
Secondary	Liver stiffness measurement (LSM)	Liver stiffness measurement (LSM) of transient elastography (TE) for each subject.	30 days
Secondary	Blood biochemical indexes (BBI) testing	APRI (Aspartate aminotransferase to Platelet Ratio Index) and FIB-4 (Fibrosis-4) were calculated through blood biochemical indexes (BBI) testing for each subject.; APRI = (AST)/(PLT)×100, FIB-4 = (Age×AST)/(PLT)×(ALT )^(1/2). ALT (Alanine transaminase), AST (Aspartate transaminase) and PLT (Platelets) counts were obtained from BBI testing.	30 days