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

KY20230428-02

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.

2023-05-01

2025-12-31

2025-12-31

Recruiting

100

Inclusion Criteria: 1. Voluntary subjects, patients or their legal representatives to sign informed consent; 2. There was no limitation on the gender of the volunteers, whose age ranged from 18 to 85 years old, including the cut-off value; 3. Myocardial injury caused by various causes was found by other imaging methods (cardiac ultrasound, coronary angiography, coronary CT, cardiac MRI, etc.); 4. Kidney GFR \> 50 ml/min, ERPF \> 280 ml/min, platelet count (PLT) \> 75 000/μL, leukocyte (WBC) \> 3000/μL, alanine aminotransferase ALT, aspartate aminotransferase AST \< 3 times the normal value. Exclusion Criteria: 1. Allergic to the same drugs (drugs with similar chemical or biological components to fibroblast activating protein inhibitors), allergic constitution or currently suffering from allergic diseases; 2. Clinical investigators who are currently conducting clinical studies on other drugs, or who have participated in any drug (excluding vitamins and minerals); 3. Have other clinical problems that are difficult to control (such as HIV, hepatitis C virus infection or active hepatitis B, or other severe chronic infections and serious mental, neurological, respiratory and other diseases); 4. Red blood cell RBC is less than 4×1012, white blood cell WBC is less than 3×109, hemoglobin is less than 80g/L, PLT is less than 75,000 ×109; 5. Significantly abnormal liver and kidney function, GFR less than 20 ml/min; 6. Cardiac ejection fraction (EF) was assessed to be less than 10%; 7. The expected survival time is less than half a year; Coronary stent implantation within 2 weeks or coronary artery bypass graft within 6 months; 8. Severe acute concomitant disease or severe refractory mental disorder; 9. Pregnant and lactating women (pregnancy is defined as positive in blood pregnancy studies); 10. Patients whose physical conditions are not suitable for radioactive examination; 11. Patients with metal implants (pacemakers, etc.) or spatial claustrophobia or other MRI related contraindications; 12. Any situation that the presiding officer of this study believes may cause harm or potential harm to any link related to this test.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-05-22