Evaluating PET/MRI for cardiac sarcoidosis prognosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the prognostic value of combined PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging) in patients with suspected cardiac sarcoidosis. By improving diagnostic performance, the study seeks to better stratify risks, particularly for sudden cardiac events, and enhance the management of patients through targeted therapies. The hypothesis is that PET/MRI can effectively differentiate between fibrosis and granulomatous lesions, providing valuable insights into the therapeutic response. This innovative approach could lead to improved patient outcomes in managing cardiac sarcoidosis.

Why it matters

Who can join: the full rules

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

Where it's running

• Henri Mondor Hospital
  Créteil, France Recruiting

Study contacts

• Study coordinator: Vania TACHER, PHD
• Email: vania.tacher@aphp.fr
• Phone: 01 49 81 29 29

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Al[18F]F-NOTA-folate PET imaging in suspected cardiac sarcoidosis and infective endocarditis

  This diagnostic test uses a folate-based PET tracer to see if it can help identify inflammation or infection in the heart for people with suspected cardiac sarcoidosis or infective endocarditis.

  Recruiting Turku University Hospital · Turku · NCT07814222

• Exosome-based biomarkers for cardiac sarcoidosis activity

  Researchers will test blood exosomes to see if they reveal activity of cardiac sarcoidosis in patients with and without the condition, using usual care FDG-PET data.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07604220

• Using advanced heart MRI to improve diagnosis and risk prediction for rare cardiomyopathies

  This project tests whether advanced cardiac MRI techniques can help diagnose and predict future risk for people with rare heart muscle diseases like Danon, Fabry, cardiac amyloidosis, Noonan syndrome, and cardiac sarcoidosis.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07336394

• Tc-99m Tilmanocept SPECT/CT imaging for detecting cardiac sarcoidosis

  This trial tries to see if a Tc-99m Tilmanocept SPECT/CT scan can detect cardiac sarcoidosis in adults.

  Recruiting Phase 2 Duke University · Durham, North Carolina · NCT07159074

• Evaluating rilonacept for treating cardiac sarcoidosis

  This study tests if adding a new drug called rilonacept to regular treatment can help adults with cardiac sarcoidosis reduce inflammation in their hearts.

  Recruiting at 2 sites Phase 2 Mayo Clinic · Baltimore, Maryland and 1 other locations · NCT06660732

• Using SGLT1/2 inhibitors to improve heart imaging in healthy volunteers

  This study is testing whether a new diabetes medication can help improve heart imaging in healthy volunteers by better controlling how the heart uses sugar during scans.

  Recruiting University of Pennsylvania · Philadelphia, Pennsylvania · NCT06510894

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.