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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGStandardized uptake value (SUV)
Standardized uptake value (SUV) of 68Ga-FAPI-04 for each target lesion of subject or suspected liver fibrosis.
Time frame: 30 days
Liver stiffness measurement (LSM)
Liver stiffness measurement (LSM) of transient elastography (TE) for each subject.
Time frame: 30 days
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.
Time frame: 30 days
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