Study of Novel PET Tracer Gallium [68Ga]/ Fluorine [18F] -FAPI-04 in the Diagnosis of Cardiovascular Diseases
Myocardial Fibrosis
About this trial
This is an interventional diagnostic trial for Myocardial Fibrosis focused on measuring Fibroblast Activation Protein, PET-MRI,myocardial fibrosis
Eligibility Criteria
Inclusion Criteria: Voluntary subjects, patients or their legal representatives to sign informed consent; There was no limitation on the gender of the volunteers, whose age ranged from 18 to 85 years old, including the cut-off value; Myocardial injury caused by various causes was found by other imaging methods (cardiac ultrasound, coronary angiography, coronary CT, cardiac MRI, etc.); 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: 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; Clinical investigators who are currently conducting clinical studies on other drugs, or who have participated in any drug (excluding vitamins and minerals); 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); 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; Significantly abnormal liver and kidney function, GFR less than 20 ml/min; Cardiac ejection fraction (EF) was assessed to be less than 10%; The expected survival time is less than half a year; Coronary stent implantation within 2 weeks or coronary artery bypass graft within 6 months; Severe acute concomitant disease or severe refractory mental disorder; Pregnant and lactating women (pregnancy is defined as positive in blood pregnancy studies); Patients whose physical conditions are not suitable for radioactive examination; Patients with metal implants (pacemakers, etc.) or spatial claustrophobia or other MRI related contraindications; Any situation that the presiding officer of this study believes may cause harm or potential harm to any link related to this test.
Sites / Locations
- Nanjing First HospitalRecruiting
Arms of the Study
Arm 1
Experimental
68Ga/18F-FAPI-04
For the injection, subjects will receive a target dose of 0.1~0.15mCi/Kg 68Ga/18F-FAPI-04 as a bolus injection.