Liver Fibrosis, Positron Emission Tomography
Conditions
Brief 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.
Detailed 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.
Interventions
DRUG68Ga-FAPI-04
Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value (SUV) | 30 days | Standardized uptake value (SUV) of 68Ga-FAPI-04 for each target lesion of subject or suspected liver fibrosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver stiffness measurement (LSM) | 30 days | Liver stiffness measurement (LSM) of transient elastography (TE) for each subject. |
| Blood biochemical indexes (BBI) testing | 30 days | 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. |
Countries
China
Contacts
Primary ContactWeibing Miao, M.D.
Backup ContactChao Huang
Outcome results
None listed