Using a new PET tracer to diagnose heart disease
Study of Novel PET Tracer Gallium [68Ga]/ Fluorine [18F] -FAPI-04 in the Diagnosis of Cardiovascular Diseases
This study is testing a new imaging agent to see if it can help doctors diagnose heart disease earlier in patients with heart failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05867589 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a novel imaging agent, 68Ga/18F-FAPI-04, for diagnosing myocardial fibrosis associated with cardiovascular diseases. It combines PET imaging with MRI technology to monitor the progression of myocardial fibrosis in heart failure patients. The goal is to establish a comprehensive imaging protocol that can aid in the early detection and treatment of heart conditions. By integrating nuclear medicine and magnetic resonance imaging, the study aims to enhance diagnostic capabilities in cardiology.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with myocardial injury identified through other imaging methods.
Not a fit: Patients with allergies to fibroblast activating protein inhibitors or those currently involved in other clinical studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and management of myocardial fibrosis in patients with heart failure.
How similar studies have performed: While the approach of combining PET and MRI is innovative, similar studies have shown promise in enhancing diagnostic accuracy for cardiovascular conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Feng Wang
- Email: fengwangcn@hotmail.com
- Phone: 02552271491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.