NCT05867589

Study of Novel PET Tracer Gallium [68Ga]/ Fluorine [18F] -FAPI-04 in the Diagnosis of Cardiovascular Diseases

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of fibroblast activating protein receptor imaging agent \[68Ga\]/ Fluorine \[18F\] -fibroblast activating protein inhibitor (68Ga/18F-FAPI-04) in clinical application and to verify its effectiveness in the diagnosis of cardiovascular diseases.

Detailed description

The implementation of this project will promote the research of PET-MRI molecular imaging using the new nuclide imaging with the target of FAP combined with the MRI T1 mapping and ECV measurement technology, realize the fusion of nuclear medicine and magnetic resonance technology in a real sense, dynamically monitor the occurrence and development of myocardial fibrosis in heart failure at an early stage, and establish a complete set of myocardial fibrosis imaging programs. To provide an important basis for the exploration of anti-fibrosis therapy in heart failure and accelerate the pace of clinical transformation of this protocol.

Conditions

• Myocardial Fibrosis

Interventions

Type	Name	Description
DRUG	68Ga/18F-FAPI-04	Subjects will receive one injection of 68Ga/18F-FAPI-04 (0.1\~0.15mCi/Kg), a PET radiopharmaceutical selective for fibroblast activation protein. 68Ga/18F-FAPI-04 injection will be followed by a 10 ml saline flush.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-05-22
• Last updated: 2023-05-22

Locations

1 site across 1 country: China