NCT04831034

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: First Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibrosis
• Positron-Emission Tomography

Interventions

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

Timeline

• Start date: 2021-04-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2021-04-05
• Last updated: 2023-09-21

Locations

1 site across 1 country: China