68Ga-FAPI PET/CT in Liver Fibrosis Patients (GFAPILF)

Fujian Medical University (FJMU)

Status and phase

Enrolling

Early Phase 1

Conditions

Liver Fibrosis

Positron Emission Tomography

Treatments

Drug: 68Ga-FAPI-04

Study type

Interventional

Funder types

Other

Identifiers

NCT04533828

FAPILF

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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