68Ga-FAPI PET/CT in Liver Fibrosis Patients

Early Phase 1

• Conditions: Positron Emission Tomography; Liver Fibrosis
• Interventions: Drug: 68Ga-FAPI-04

• Registration Number: NCT04533828
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

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.

Study Timeline

• Study First Submitted: 2020-08-22
• Study First Submitted QC: 2020-08-29
• Status Verified: 2020-09
• Study Start: 2020-09-01
• Study First Posted: 2020-09-01
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-03
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China