68Ga-FAPI PET combined with cardiac MRI for heart disease
Clinical Research on 68Ga-FAPI PET/CMR in Cardiovascular Diseases
This project will test whether 68Ga-FAPI PET together with cardiac MRI can find early scarring (fibrosis) of the heart muscle in adults with cardiovascular disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai East Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07063043 on ClinicalTrials.gov |
What this trial studies
This is an observational imaging protocol using 68Ga-labeled FAP inhibitor (FAPI) PET performed alongside cardiac magnetic resonance (CMR) to detect myocardial fibrosis in adults with confirmed cardiovascular disease. Participants undergo noninvasive PET/CMR imaging at Shanghai East Hospital without therapeutic intervention, and imaging findings will be correlated with clinical data and standard cardiac assessments. The approach leverages FAP-targeted radiotracers to visualize activated fibroblasts and uses CMR to provide detailed structural and functional information without additional ionizing radiation from the MRI component. The study focuses on adult patients who are clinically stable and able to undergo MRI.
Who should consider this trial
Good fit: Adults over 18 with a confirmed diagnosis of cardiovascular disease who are clinically stable, able to give informed consent, and eligible for MRI are ideal candidates.
Not a fit: Patients with MRI-incompatible implanted devices, claustrophobia, pregnancy or lactation, a history of malignancy, or those without myocardial fibrotic changes are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could enable earlier, noninvasive detection of myocardial fibrosis and help guide more personalized treatment decisions.
How similar studies have performed: Early studies using 68Ga-FAPI PET have shown promising ability to image myocardial fibrosis, but combining PET with CMR is a newer approach that has limited large-scale validation to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have a confirmed clinical diagnosis of cardiovascular disease by a cardiologist, based on genetic testing, family history, and comprehensive clinical evaluation including physical examination, echocardiography, and when indicated, cardiac MRI findings. * Age requirement: \>18 years. * Patients should demonstrate stable cardiovascular status without significant changes in symptoms, treatment, or clinical findings for a specified pre-enrollment period. * Participants must be capable of providing informed consent and willing to adhere to all study requirements, including follow-up procedures. Exclusion Criteria: * History of malignancy * Documented cardiovascular diseases, including coronary artery disease, myocardial infarction, or related conditions * Implanted metallic devices (e.g., pacemakers, aneurysm clips) or other MRI-incompatible medical prostheses * Claustrophobia * Pregnancy or lactation * Known hypersensitivity to gadolinium-based contrast agents * Renal impairment (eGFR \<30 mL/min/1.73m² by CKD-EPI equation)
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jie Ding, MD
- Email: dingjie940406@163.com
- Phone: 086-38804518
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.