Actively Recruiting
Prospective Comparative Multicenter Study Evaluating 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Cardiac damage is a major cause of death in patients with sarcoidosis, second only to lung damage. Researchers are studying the use of combined PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging) scans as a way to better diagnose and predict the progression of cardiac sarcoidosis. This approach aims to improve risk assessment, especially for sudden death, and to help guide therapies and device implantation. Participants with suspected cardiac sarcoidosis will undergo PET/MRI scans using a new hybrid camera that conducts FDG positron emission tomography along with gadolinium-enhanced MRI. This diagnostic method may help distinguish between fibrotic scarring and active granulomatous lesions and assess how patients respond to treatment. The study is prospective and comparative, involving multiple centers. During the study, researchers will monitor participants for up to 24 months, tracking occurrences of severe heart-related events. They will assess diagnostic accuracy, compare imaging results before and after treatment at 3 and 12 months, and evaluate metabolic activity and tissue changes. The study involves consented adults with sarcoidosis who have signs or symptoms suggesting cardiac involvement. Regular follow-up includes imaging assessments and clinical monitoring to evaluate prognosis and therapeutic response.
CONDITIONS
Brief Title
Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Sarcoidosis diagnosed according to ATS/ERS/WASOG criteria
- Suspicion of cardiac involvement based on symptoms like syncope, palpitations, or heart failure signs
- Presence of cardiac rhythm or conduction disorders such as Mobitz type 2 AV block, ventricular arrhythmias, or bundle branch block
- Compatible cardiac ultrasound abnormalities like left ventricular dilation or segmental wall motion abnormalities
- Informed consent provided
- Membership in a social security scheme
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 impairment (clearance less than 30 mL/min/1.73m2)
- Implanted pacemakers or devices incompatible with 3 Tesla MRI
- Presence of certain metallic implants or electronic medical devices
- Inability or refusal to follow a low-carbohydrate diet and fasting before imaging
- Inability to hold breath for 10 seconds
- Legal restrictions like judicial or administrative detention
- Under legal protection such as guardianship or curatorship
- Participation in other interventional research or within exclusion period after such research
- Patients under AME program
- Positive pregnancy test after consent for women of reproductive age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo PET/MRI imaging to evaluate cardiac sarcoidosis and assess prognostic markers.
Assessments at baseline and follow-up imaging up to 24 months
Trial Site Locations
Total: 1 location
1
Henri Mondor Hospital
Créteil, France
Actively Recruiting
Research Team
V
Vania TACHER, PHD
S
Samia BALOUL
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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