Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05954507

Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-02

180

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of sarcoidosis according to ATS/ERS/WASOG criteria
  • Suspicion of cardiac involvement based on clinical symptoms (such as syncope, palpitations, heart failure signs), or cardiac rhythm or conduction disorders, or compatible cardiac ultrasound abnormalities
  • Provided informed consent
  • Member of a social security scheme
Not Eligible

You will not qualify if you...

  • Uncontrolled psychiatric illness
  • Claustrophobia
  • Known pregnancy or breastfeeding
  • Unbalanced diabetes affecting carbohydrate metabolism
  • Previous heart attack or known coronary disease
  • Allergy to gadolinium, fluoro-desoxyglucose, or their components
  • Severe kidney failure (creatinine clearance < 30 mL/min/1.73m2)
  • Implanted pacemaker incompatible with a 3 Tesla MRI
  • Presence of ocular metallic foreign bodies or certain implanted electronic devices (neurostimulators, cochlear implants, metallic heart valves, vascular clips)
  • Unable or unwilling to follow a low-carbohydrate diet for 24 hours plus 6-hour fast before scan
  • Unable to hold breath for 10 seconds during examination
  • Legal restrictions such as deprivation of liberty or legal protection
  • Participation in other interventional studies or within exclusion period
  • Patients under AME
  • Positive pregnancy test after inclusion for women of reproductive age

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Henri Mondor Hospital

Créteil, France

Actively Recruiting

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Research Team

V

Vania TACHER, PHD

CONTACT

S

Samia BALOUL

CONTACT

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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Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis | DecenTrialz