Clinical Application of Fibroblast Activation Protein PET/MRI in Liver Fibrosis

Magnetic Resonance Imaging Clinical Trial

Official title:

Clinical Application of Fibroblast Activation Protein PET/MRI for Diagnosis and Staging in Liver Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04605939
• Other study ID #: XLan-0507
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Wuhan Union Hospital, China
• Contact: Xiaoli Lan, PhD
• Phone: 0086-027-83692633
• Email: lxl730724[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and staging of liver fibrosis. Activation of hepatic stellate cell (HSC) is a key link in the pathophysiological development of liver fibrosis. In human liver tissue, fibroblast activation protein (FAP) was only expressed in active HSCs and fibroblasts, but not in static HSCs. Therefore, FAP has become an excellent target for diagnosis and treatment of liver fibrosis. Recently, radionuclide-labeled fibroblast activation protein inhibitors (FAPI) as a new novel positron tracer has shown to be effective to detect various cancers. In this prospective study, the investigators will use the most advanced imaging equipments, integrated PET/MR, and PET/CT with gallium-68 (68Ga) -FAPI to image patients with or suspected of liver fibrosis, the aim is to explore the value of 68Ga-FAPI hybrid PET/MR and PET/CT in liver fibrosis.

Description:

Liver fibrosis is a key step in the development of various chronic liver diseases (viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, autoimmune liver disease, etc.) to cirrhosis and an important link that affects the prognosis of chronic liver disease. Fibrosis is histologically reversible, and early liver fibrosis can still be reversed to restore liver tissue to normal. However, due to the lack of specific initial symptoms and accurate non-invasive diagnostic methods, the onset of liver fibrosis is insidious. Most patients have developed liver cirrhosis and/or hepatocellular carcinoma when they are diagnosed, and some even require liver transplantation. If liver fibrosis can be diagnosed accurately and treated early, the prognosis of chronic liver disease can be improved.

Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and staging of liver fibrosis. Activation of hepatic stellate cell (HSC) is a key link in the pathophysiological development of liver fibrosis. In human liver tissue, fibroblast activation protein (FAP) was only expressed in active HSCs and fibroblasts, but not in static HSCs. Therefore, FAP has become an excellent target for diagnosis and treatment of liver fibrosis. Recently, radionuclide-labeled fibroblast activation protein inhibitors (FAPI) as a new novel positron tracer has shown to be effective to detect various cancers. In this prospective study, the investigators will use the most advanced imaging equipments, integrated PET/MR, and PET/CT with gallium-68 (68Ga) -FAPI to image patients with or suspected of liver fibrosis, the aim is to explore the value of 68Ga-FAPI hybrid PET/MR and PET/CT in liver fibrosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with suspected or diagnosed or treated liver fibrosis.

• Subjects are able to understand and sign the informed consent voluntarily, with good compliance.

Exclusion Criteria:

• Acute systemic diseases and electrolyte disorders.

• Pregnant or lactating women.

• Patients refuse to sign the informed consent.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis
• Magnetic Resonance Imaging
• Positron Emission Tomography

Intervention

Device:
• PET/MR
Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
• PET/CT
Each subject undergoes PET/CT imaging within 40-60 minutes after injection.

Locations

Country	Name	City	State
China	China, Hubei Province	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of 68Ga-DOTA-FAPI PET/MR for diagnosis and staging in liver fibrosis.	For 100 subjects with suspected or diagnosed or treated liver fibrosis who have completed 18F-FDG PET/CT imaging, diagnosis and staging results of 68Ga-DOTA-FAPI PET/MR, PET/CT will be compared to transient elastography(TE), pathology, clinical and follow-up result.	2 years
Primary	Correlation of 68Ga-DOTA-FAPI PET/MR parameters and liver fibrosis progression.	Analyze the correlation between the parameters displayed by 68Ga-DOTA-FAPI PET/MR and the pathological staging of liver fibrosis, serological scores, etc.	2 years