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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa

About this trial

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an inherited heart muscle disease associated with fibrofatty myocardial replacement, ventricular arrhythmias, and an increased risk of sudden cardiac death. Although current diagnostic approaches, including the 2010 Task Force Criteria and the Padua criteria, improve recognition of the disease, early diagnosis remains challenging, particularly when structural abnormalities are subtle or absent on conventional imaging. Echocardiography and cardiac magnetic resonance imaging are central to evaluation, but their sensitivity for early or active fibrotic remodeling may be limited. This limitation may be particularly relevant in patients who are unable to undergo cardiac magnetic resonance imaging, in whom 68Ga-DOTA-SA-FAPI PET/CT may provide complementary diagnostic information.

This prospective single-group diagnostic imaging study aims to investigate the incremental value of protocol-specified 68Ga-DOTA-SA-FAPI PET/CT imaging in patients with ARVC. FAPI PET/CT is a novel molecular imaging method that targets activated fibroblasts and may allow non-invasive detection of active myocardial fibrosis.Fifteen adult patients with an established diagnosis of ARVC will undergo protocol-specified 68Ga-DOTA-SA-FAPI PET/CT imaging in addition to clinical evaluation, electrocardiography, echocardiography, and review of previously obtained cardiac magnetic resonance imaging findings. FAPI PET/CT findings will be compared with conventional diagnostic criteria and other clinical and imaging parameters, including previously available cardiac magnetic resonance imaging findings. Participants will also be followed clinically for 6 months after imaging to explore possible associations between FAPI uptake and short-term clinical outcomes, including arrhythmic events, ventricular function, and laboratory markers.

The study is expected to provide preliminary evidence on whether 68Ga-DOTA-SA-FAPI PET/CT may improve the detection of myocardial fibrosis and contribute to diagnostic assessment and risk stratification in ARVC. It may also help clarify the potential role of FAPI PET/CT in patients who are unable to undergo cardiac magnetic resonance imaging. The findings may support future larger prospective studies in this field.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of malignancy

Severe renal impairment

Severe hepatic impairment

Pregnancy or breastfeeding

Trial design

Design model

Single group

Treatments tested in this trial

  • 68Ga-DOTA-SA-FAPI PET/CT

    Diagnostic test

    Protocol-specified 68Ga-DOTA-SA-FAPI positron emission tomography/computed tomography performed for assessment of myocardial fibroblast-related remodeling in patients with arrhythmogenic right ventricular cardiomyopathy. The imaging protocol includes intravenous administration of approximately 150-200 MBq of 68Ga-DOTA-SA-FAPI, an uptake period of 40-60 minutes, low-dose CT for attenuation correction and anatomical localization, and thoracic PET acquisition for cardiac assessment.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Adults With ARVCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Myocardial 68Ga-DOTA-SA-FAPI Uptake on PET/CT

Presence and distribution of myocardial 68Ga-DOTA-SA-FAPI uptake on PET/CT, assessed qualitatively and, where feasible, semi-quantitatively by maximum standardized uptake value (SUVmax).

Time frame
At baseline (time of PET/CT imaging)

Secondary outcomes

1

Correlation Between Myocardial FAPI PET/CT Uptake and Fibrosis-Related Findings on Previously Obtained Cardiac Magnetic Resonance Imaging

Correlation between myocardial 68Ga-DOTA-SA-FAPI uptake on PET/CT and fibrosis-related abnormalities identified on previously obtained cardiac magnetic resonance imaging.

Time frame
At baseline
2

Correlation Between Myocardial FAPI PET/CT Uptake and Right Ventricular Fractional Area Change on Transthoracic Echocardiography

Correlation between myocardial 68Ga-DOTA-SA-FAPI uptake on PET/CT and right ventricular fractional area change measured by transthoracic echocardiography.

Time frame
At baseline
3

Incidence of Arrhythmic Events During 6-Month Follow-Up

Incidence of documented arrhythmic events during the 6 months following baseline 68Ga-DOTA-SA-FAPI PET/CT imaging.

Time frame
Within 6 months after PET/CT imaging
4

Diagnostic Concordance Rate Between FAPI PET/CT and Previously Obtained Cardiac Magnetic Resonance Imaging

Concordance rate between myocardial abnormalities detected by 68Ga-DOTA-SA-FAPI PET/CT and fibrosis-related abnormalities identified on previously obtained cardiac magnetic resonance imaging.

Time frame
At baseline

Other outcomes

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