68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease

Early Phase 1

Recruiting

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

• Registration Number: NCT04831034
• 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 fibrotic disease

Detailed Description

Subjects with fibrotic disease underwent 68Ga-FAPI-04 PET/CT scanning. Fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax). Subjects also received the conventional clinical assessment for liver fibrosis, such as magnetic resonance imaging(MRI) , biopsy 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, MRI and BBI were calculated and compared to evaluate the diagnostic efficacy.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• adult patients (aged 18 years or order)
• patients with suspected or new diagnosed fibrotic disease (supporting evidence may include , 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 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	68Ga-FAPI-04	Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value (SUV)	30 days	Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject.

Secondary Outcome Measures

Name	Time	Method
Diagnostic efficacy	30 days	The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.

Trial Locations

Locations (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China