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

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · May 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging agent called 68Ga/18F-FAPI-04, which is designed to help doctors see and diagnose heart conditions, specifically a problem known as myocardial fibrosis. Myocardial fibrosis happens when the heart muscle becomes stiff or thick, making it harder for the heart to pump blood effectively. The goal of the study is to determine how safe this imaging agent is and how well it works in identifying cardiovascular diseases.

To participate in this trial, individuals must be between 18 and 85 years old and have signs of heart injury identified through other imaging tests such as ultrasounds or MRIs. Participants should also have good kidney function and meet certain blood count requirements. However, people with severe allergies, certain chronic illnesses, or specific recent heart procedures are not eligible. If you join the study, you can expect to undergo imaging tests using the new agent, which may help improve future heart disease diagnoses. Overall, this research could lead to better tools for detecting heart issues early on, ultimately helping patients receive timely and effective treatment.

Gender

ALL

Eligibility 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.