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

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Criteria

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.