Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis (SARCASTIM)

Prospective Comparative Multicenter Study Evaluating the Prognostic Interest of PET/MRI in Cardiac Sarcoidosis

Cardiac damage is the second leading cause of death in patients with sarcoidosis, after lung damage. Today's challenge is to diagnose the disease as effectively as possible, and to develop tools for better risk stratification, especially for sudden death, in order to better target therapies and implantable devices, such as corticoids and immunosuppressant.

The hypothesis is that combined PET (Positron Emission Tomography)/MRI (Magnetic Resonance Imaging) could be a relevant prognostic marker of progression, and would significantly improve diagnostic performance in patients with suspected cardiac sarcoidosis (CS). This study will also make it possible to distinguish sequellar fibrosis lesions from granulomatous lesions and assess the therapeutic response. Incorporating PET/MRI into the diagnostic strategy for patients with suspected CS could therefore improve their management.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Sarcoidosis
• Intervention / Treatment: Diagnostic test: PET/MRI

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vania TACHER, PHD; Phone Number: 01 49 81 29 29; Email: vania.tacher@aphp.fr
• Study Contact Backup: Name: Samia BALOUL; Phone Number: 01 49 81 33 85; Email: samia.baloul@aphp.fr

Study Locations

• France
  • Créteil, France
    • Recruiting
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Sarcoidosis defined according to ATS/ERS/WASOG criteria

• Suspicion of cardiac involvement in sarcoidosis:

  • Clinical manifestations (syncope, lipothymia, persistent palpitations, signs of heart failure) and/or
  • Cardiac rhythm or conduction disorder (Mobitz type 2 atrioventricular block (AVB), AVB 3, right or left bundle branch block, Q wave in at least 2 leads, ventricular arrhythmia (ventricular mono/polymorphic complexes> 1000 per 24 h, ventricular tachycardia, ventricular fibrillation), unexplained sustained VT or epsilon wave) and/or
  • Compatible cardiac ultrasound abnormality: left ventricular dilatation, septal thickening or wall thinning (especially basal), segmental kinetic disorder and wall aneurysm without coronary anomaly, altered left ventricular ejection fraction, altered diastolic function, altered right ventricular systolic function.
• Informed patient consent
• Membership of a social security scheme

Exclusion Criteria:

• Psychiatric illness not controlled by treatment
• Claustrophobia
• Known pregnancy or breast-feeding patient
• Unbalanced diabetes (influence on carbohydrate metabolism for PET)
• Previous infarction or known coronary disease
• Known allergy to gadolinium and fluoro-desoxyglucose and their excipients
• Renal insufficiency (Clairance < 30 mL/min/1.73m2)
• Implanted pacemaker not compatible with a 3 Teslas magnetic field
• Patients with ocular metallic foreign bodies, pacemakers, neurostimulators, cochlear implants, metallic heart valves, vascular clips formerly implanted on cranial aneurysms and, in general, any non-removably implanted electronic medical equipment
• Inability or refusal to follow a low-carbohydrate diet for 24 hours, followed by a 6-hour fast required prior to the examination
• Patient unable to hold a 10-second apnea.
• Patient deprived of liberty by judicial or administrative decision
• Patient under legal protection (guardianship, curatorship)
• Participation in other interventional research involving the human person or being in the exclusion period following previous research involving the human person
• Patients under AME

Exclusion criteria (post signature of consent) for women of reproductive age :

- Positive pregnancy test result after inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Prospective cohort of patients; Patients with suspected cardiac sarcoidosis	Diagnostic test: PET/MRI; PET/MRI is a new-generation hybrid camera capable of simultaneously performing FDG positron emission tomography and gadolinium-injected MRI. PET/MRI could be a relevant prognostic marker of progression, and could significantly improve diagnostic performance in patients with suspected cardiac sarcoidosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of a severe cardiological event	Occurrence during follow-up of at least one of the severe cardiological events listed below attributed to sarcoidosis, assessed at 24 months: Death from cardiac causes.; Placement of an automatic implantable defibrillator or pacemaker.; Conduction disorder (Mobitz type 2 atrioventricular block (AVB), AVB 3, ventricular arrhythmia (ventricular mono/polymorphic complexes > 1000 per 24 h, ventricular tachycardia (VT), ventricular fibrillation), unexplained sustained VT).; Degradation of cardiac function of more than 10% of LVEF assessed by transthoracic (TTE) or cardiac MRI.; Acute heart failure with no other known cause	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of severe cardiological events between patients with and without Delayde MRI enhancement	Among patients with hypermetabolic FDG PET uptake	Up to 24 months.
Frequency of severe cardiological events according to each modality of PET/MRI results in terms of Delayde MRI enhancement and hypermetabolic fixation on PET.	MRI- PET-; MRI- PET+; MRI+ PET-; and MRI+ PET+.	Up to month 24.
Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement	Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement (absent, possible, probable or very probable) by each examination (MRI alone, PET alone, or PET/MRI) in relation to the diagnosis established at two years (reference).	Up to month 24.
Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment.	For patients with initial pathological MRI-PET.	Up to month 3 and 12.

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Matthieu MAHEVAS, PHD, Assistance public Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2025
• Primary Completion (Estimated): March 7, 2030
• Study Completion (Estimated): March 7, 2030

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: MRI; PET; Cardiac sarcoidosis; Combined PET/MRI
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Lymphatic Diseases; Lymphoproliferative Disorders; Hypersensitivity, Delayed; Sarcoidosis
• Other Study ID Numbers: APHP191100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No