Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07563660

Incremental Diagnostic and Prognostic Value of 68Ga-DOTA-SA-FAPI PET/CT Imaging in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Led by Istanbul University - Cerrahpasa · Updated on 2026-05-04

15

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an inherited heart muscle disease causing fibrofatty replacement of the heart muscle, ventricular arrhythmias, and increased risk of sudden cardiac death. Early diagnosis is difficult, especially when structural changes are subtle or missing on standard imaging like echocardiography and cardiac magnetic resonance imaging (MRI). This study evaluates whether a new imaging method, 68Ga-DOTA-SA-FAPI PET/CT, which detects active fibrosis by targeting activated fibroblasts, can improve diagnosis and risk assessment in adults with ARVC. Fifteen adult patients with confirmed ARVC will undergo 68Ga-DOTA-SA-FAPI PET/CT imaging alongside clinical evaluation, electrocardiography, echocardiography, and review of previously performed cardiac MRI. The PET/CT involves injecting a tracer, resting for 40-60 minutes, and then imaging the heart to assess fibroblast activity. No new cardiac MRI will be done as part of the study. The study aims to compare PET/CT findings with conventional imaging and clinical data, including in patients who cannot have cardiac MRI. Participants will be monitored clinically for six months after imaging to observe any arrhythmic events, heart function changes, and laboratory markers. The study will assess whether PET/CT provides additional information about active myocardial fibrosis that could aid diagnosis and risk stratification in ARVC. Data will be collected confidentially, and results may support larger future studies on molecular imaging in inherited cardiomyopathies.

CONDITIONS

Brief Title

FAPI PET/CT Imaging in Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) (FAPI-ARVC))

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 could interfere with study participation, image interpretation, or completion of follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo protocol-specified 68Ga-DOTA-SA-FAPI PET/CT imaging to assess myocardial fibroblast-related remodeling, along with clinical evaluation, 12-lead electrocardiography, transthoracic echocardiography, and review of previously obtained cardiac magnetic resonance imaging findings.

1 visit (in-person)

Long-term Monitoring

Duration - 6 months

Participants are followed clinically for 6 months after PET/CT imaging to monitor arrhythmic events, clinical status, routine electrocardiographic findings, echocardiographic reassessment where available, and selected laboratory parameters obtained during standard care.

Periodic visits as part of standard care

Trial Site Locations

Total: 1 location

1

Istanbul University-Cerrahpasa Institute of Cardiology

Istanbul, Fatih, Turkey (Türkiye)

Actively Recruiting

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Research Team

S

Sukru Arslan, MD, Associate Professor

S

Sahra Asena Balcioglu, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Prevalence of 18F-fluorodeoxyglucose positron emission tomography abnormalities in patients with arrhythmogenic right ventricular cardiomyopathy.

Alexandros Protonotarios, Eleanor Wicks, Michael Ashworth...

https://pubmed.ncbi.nlm.nih.gov/30409737

18F-Fluorodeoxyglucose Positron Emission Tomography for the Detection of Myocardial Inflammation in Arrhythmogenic Left Ventricular Cardiomyopathy.

Roxane Tessier, Lara Marteau, Marc Vivien...

https://pubmed.ncbi.nlm.nih.gov/35770631

Arrhythmic risk prediction in arrhythmogenic right ventricular cardiomyopathy: external validation of the arrhythmogenic right ventricular cardiomyopathy risk calculator.

Paloma Jordà, Laurens P Bosman, Alessio Gasperetti...

https://pubmed.ncbi.nlm.nih.gov/35766180

Diagnosis of arrhythmogenic right ventricular cardiomyopathy/dysplasia: proposed modification of the task force criteria.

Frank I Marcus, William J McKenna, Duane Sherrill...

https://pubmed.ncbi.nlm.nih.gov/20172911