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

NCT07563660 | Recruiting

• 1 other identifier: 2025/1410112IUC
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arrhythmogenic Right Ventricular Cardiomyopathy; FAPI PET; Cardiac Magnetic Resonance Imaging

Keywords

Arrhythmogenic Right Ventricular Cardiomyopathy; Fibroblast Activation Protein; Positron Emission Tomography Computed Tomography; Molecular Cardiac Imaging; Sudden Cardiac Death Risk Stratification; Inherited Cardiomyopathy; Cardiac Magnetic Resonance Imaging; Myocardial Fibrosis

Outcome Measures

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).

  At baseline (time of PET/CT imaging)

Secondary Outcomes (6)

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

  At baseline

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

  At baseline

• Incidence of Arrhythmic Events During 6-Month Follow-Up

  Within 6 months after PET/CT imaging

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

  At baseline

• Diagnostic Concordance Between FAPI PET/CT and Established ARVC Evaluation

  At baseline

Study Arms (1)

Adults With ARVC

EXPERIMENTAL

Participants in this single-arm diagnostic imaging study will undergo protocol-specified 68Ga-DOTA-SA-FAPI PET/CT for assessment of myocardial fibroblast-related remodeling in arrhythmogenic right ventricular cardiomyopathy. All participants will also undergo clinical evaluation, 12-lead electrocardiography, transthoracic echocardiography, and review of previously obtained cardiac magnetic resonance imaging findings, followed by 6 months of protocol-defined clinical follow-up.

Diagnostic Test: 68Ga-DOTA-SA-FAPI PET/CT

Interventions

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.

Adults With ARVC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa Institute of Cardiology

Istanbul, Fatih, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Mpanya D, Knuuti J, Saraste A. Gallium-68 fibroblast activation protein inhibitor positron emission tomography in cardiovascular disease. Front Nucl Med. 2023.

  BACKGROUND

• Protonotarios A, Wicks E, Ashworth M, Stephenson E, Guttmann O, Savvatis K, Sekhri N, Mohiddin SA, Syrris P, Menezes L, Elliott P. Prevalence of 18F-fluorodeoxyglucose positron emission tomography abnormalities in patients with arrhythmogenic right ventricular cardiomyopathy. Int J Cardiol. 2019 Jun 1;284:99-104. doi: 10.1016/j.ijcard.2018.10.083. Epub 2018 Oct 26.

  PMID: 30409737 BACKGROUND

• Corrado D, Perazzolo Marra M, Zorzi A, Beffagna G, Cipriani A, Lazzari M, Migliore F, Pilichou K, Rampazzo A, Rigato I, Rizzo S, Thiene G, Anastasakis A, Asimaki A, Bucciarelli-Ducci C, Haugaa KH, Marchlinski FE, Mazzanti A, McKenna WJ, Pantazis A, Pelliccia A, Schmied C, Sharma S, Wichter T, Bauce B, Basso C. Diagnosis of arrhythmogenic cardiomyopathy: The Padua criteria. Int J Cardiol. 2020 Nov 15;319:106-114. doi: 10.1016/j.ijcard.2020.06.005. Epub 2020 Jun 16.

  PMID: 32561223 BACKGROUND

• Tessier R, Marteau L, Vivien M, Guyomarch B, Thollet A, Fellah I, Jamet B, Sebille JC, Eugene T, Serfaty JM, Probst V, Trochu JN, Toquet C, Warin-Fresse K, Piriou N. 18F-Fluorodeoxyglucose Positron Emission Tomography for the Detection of Myocardial Inflammation in Arrhythmogenic Left Ventricular Cardiomyopathy. Circ Cardiovasc Imaging. 2022 Jul;15(7):e014065. doi: 10.1161/CIRCIMAGING.122.014065. Epub 2022 Jun 30. No abstract available.

  PMID: 35770631 BACKGROUND

• Jorda P, Bosman LP, Gasperetti A, Mazzanti A, Gourraud JB, Davies B, Frederiksen TC, Weidmann ZM, Di Marco A, Roberts JD, MacIntyre C, Seifer C, Deliniere A, Alqarawi W, Kukavica D, Minois D, Trancuccio A, Arnaud M, Targetti M, Martino A, Oliviero G, Pipilas DC, Carbucicchio C, Compagnucci P, Dello Russo A, Olivotto I, Calo L, Lubitz SA, Cutler MJ, Chevalier P, Arbelo E, Priori SG, Healey JS, Calkins H, Casella M, Jensen HK, Tondo C, Tadros R, James CA, Krahn AD, Cadrin-Tourigny J. Arrhythmic risk prediction in arrhythmogenic right ventricular cardiomyopathy: external validation of the arrhythmogenic right ventricular cardiomyopathy risk calculator. Eur Heart J. 2022 Aug 21;43(32):3041-3052. doi: 10.1093/eurheartj/ehac289.

  PMID: 35766180 BACKGROUND

• Malik N, Mukherjee M, Wu KC, Zimmerman SL, Zhan J, Calkins H, James CA, Gilotra NA, Sheikh FH, Tandri H, Kutty S, Hays AG. Multimodality Imaging in Arrhythmogenic Right Ventricular Cardiomyopathy. Circ Cardiovasc Imaging. 2022 Feb;15(2):e013725. doi: 10.1161/CIRCIMAGING.121.013725. Epub 2022 Feb 11.

  PMID: 35147040 BACKGROUND

• Marcus FI, McKenna WJ, Sherrill D, Basso C, Bauce B, Bluemke DA, Calkins H, Corrado D, Cox MG, Daubert JP, Fontaine G, Gear K, Hauer R, Nava A, Picard MH, Protonotarios N, Saffitz JE, Sanborn DM, Steinberg JS, Tandri H, Thiene G, Towbin JA, Tsatsopoulou A, Wichter T, Zareba W. Diagnosis of arrhythmogenic right ventricular cardiomyopathy/dysplasia: proposed modification of the task force criteria. Circulation. 2010 Apr 6;121(13):1533-41. doi: 10.1161/CIRCULATIONAHA.108.840827. Epub 2010 Feb 19.

  PMID: 20172911 BACKGROUND

MeSH Terms

Conditions

Arrhythmogenic Right Ventricular Dysplasia

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Cardiomyopathies; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sukru Arslan, MD, Associate Professor

CONTACT

+90 555 623 2606; sukru.arslan@iuc.edu.tr

Sahra Asena Balcioglu, MD

CONTACT

+90 530 443 3766; sahra.balcioglu@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Model Details: All enrolled participants will receive the same protocol-specified diagnostic imaging intervention consisting of 68Ga-DOTA-SA-FAPI PET/CT. No randomization or comparator intervention will be used. PET/CT findings will be evaluated in relation to clinical, electrocardiographic, echocardiographic, and previously obtained cardiac magnetic resonance imaging findings.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 4, 2026
• Study Start: April 16, 2025
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): October 26, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

TU (1)