FAPI PET/CT imaging in arrhythmogenic right ventricular cardiomyopathy
Incremental Diagnostic and Prognostic Value of 68Ga-DOTA-SA-FAPI PET/CT Imaging in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
NA · Istanbul University - Cerrahpasa · NCT07563660
This study will test whether a PET/CT scan using a 68Ga-DOTA-SA-FAPI tracer can detect active scarring in adults with ARVC and provide information beyond standard heart imaging.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istanbul University - Cerrahpasa (other) |
| Locations | 1 site (Istanbul, Fatih) |
| Trial ID | NCT07563660 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-group diagnostic imaging study using a protocol-specified 68Ga-DOTA-SA-FAPI PET/CT to image fibroblast activation in patients with established ARVC. Participants are adults under follow-up at the study center who meet 2010 Task Force and/or Padua criteria and who do not have exclusion conditions such as prior malignancy or severe organ impairment. Imaging findings will be compared to conventional assessments such as echocardiography and cardiac magnetic resonance imaging to determine incremental diagnostic information. The study aims to characterize focal or diffuse FAPI uptake patterns that may indicate active myocardial remodeling relevant to arrhythmic risk.
Who should consider this trial
Good fit: Adults aged 18 or older with an established diagnosis of ARVC by the 2010 Task Force and/or Padua criteria who are under active follow-up at the study center and can give informed consent.
Not a fit: Patients with a history of malignancy, severe renal or hepatic impairment, pregnancy or breastfeeding, prior 68Ga-DOTA-SA-FAPI PET/CT, or those unable/unwilling to consent may not receive benefit or be eligible for this imaging protocol.
Why it matters
Potential benefit: If successful, the test could help detect active myocardial remodeling earlier and add information to improve risk stratification and management decisions for people with ARVC.
How similar studies have performed: Early studies using FAPI PET for cardiac fibrosis and related conditions have shown promising signals, but application specifically to ARVC is novel and limited to small or preliminary reports.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older * Established diagnosis of arrhythmogenic right ventricular cardiomyopathy according to the 2010 Revised Task Force Criteria and/or the Padua criteria * Under active follow-up at the study center * Ability to understand the study procedures and provide written informed consent Exclusion Criteria: * History of malignancy * Severe renal impairment * Severe hepatic impairment * Pregnancy or breastfeeding * Prior 68Ga-DOTA-SA-FAPI PET/CT imaging * Inability or unwillingness to provide written informed consent * Any medical, clinical, or logistical condition that, in the opinion of the investigators, could interfere with study participation, image interpretation, or completion of follow-up
Where this trial is running
Istanbul, Fatih
- Istanbul University-Cerrahpasa Institute of Cardiology — Istanbul, Fatih, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Sukru Arslan, MD, Associate Professor
- Email: sukru.arslan@iuc.edu.tr
- Phone: +90 555 623 2606
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.
Conditions: Arrhythmogenic Right Ventricular Cardiomyopathy, FAPI PET, Cardiac Magnetic Resonance Imaging, Fibroblast Activation Protein, Positron Emission Tomography Computed Tomography, Molecular Cardiac Imaging, Sudden Cardiac Death Risk Stratification, Inherited Cardiomyopathy