Clinical trial Recruiting at 1 site Observational Ages 18 and up

68Ga-FAPI PET combined with cardiac MRI for heart disease

Official title: Clinical Research on 68Ga-FAPI PET/CMR in Cardiovascular Diseases

Run by Shanghai East Hospital · NCT07063043 · Data updated 2026-11-12

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.

More Cardiovascular Diseases (CVD) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorShanghai East Hospital
Academic / other
Drugs / interventionsradiation
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedJuly 14, 2025
Trial IDNCT07063043 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Shanghai East Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.