- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03356756
PET MRI Study in Patients With Cardiac Sarcoidosis
Diagnostic and Prognostic Significance of Combined PET/MRI in Inflammatory Cardiomyopathies and Sarcoidosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Myocarditis or inflammatory cardiomyopathy refers to inflammation of the myocardium. Sarcoidosis is a multisystem granulomatous disorder of unknown etiology, which can result in myocardial inflammation. Approximately 5% of patients with sarcoidosis have clinically apparent cardiac involvement, yet autopsy series indicate that cardiac involvement is present in up to 25% of cases. This discrepancy suggests that cardiac sarcoidosis may be under-diagnosed in clinical practice. Recent studies have demonstrated high diagnostic accuracy of both cardiac MRI and 18F-labelled fluoro-2-deoxyglucose (FDG) PET for detection of cardiac involvement. However, cardiac MRI may fail to identify areas of active inflammation even with fluid sensitive T2-weighted sequences.
Fasting 18F-FDG positron emission tomography (PET) has been shown to identify early cardiac sarcoidosis with relatively high sensitivity. To date, simultaneous PET/MRI evaluation of cardiac inflammation and sarcoidosis has only been described in limited case reports. The objective of the proposed research is to evaluate the utility of simultaneous PET/MRI imaging in patients with cardiac sarcoidosis and other inflammatory cardiomyopathies.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Recruiting
- University Health Network
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The primary criterion for enrolment will be patients ≥18 years of age with known or suspected sarcoidosis or other inflammatory cardiomyopathy who are referred for clinically indicated 18F-FDG PET/CT imaging
Exclusion Criteria:
- Standard cardiac MRI contraindications include arrhythmia, claustrophobia, history of allergic reaction or other contraindication to gadolinium-based contrast agent, impaired renal function with eGFR < 60 ml/min/1.73m2, pregnancy, breast-feeding, or any other general contraindication to MRI (pacemaker, cerebral aneurysm clips, shrapnel, etc).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PET MRI exam
simultaneous combined 18F-FDG PET and cardiac MRI imaging (PET MRI) performed immediately after the PET CT exam.
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Patients will undergo a research study performed with an integrated whole-body PET/MRI imaging system designed for simultaneous PET and MRI acquisition, immediately after standard of care PET/CT exam.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incremental value of combined 18F-FDG PET and cardiac MRI imaging in the evaluation of patients with suspected cardiac sarcoidosis or cardiac inflammation
Time Frame: Completion of enrollment, an average of two years
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Patients will undergo standard clinical evaluation using modified consensus guidelines for the diagnosis of sarcoidosis.
Following enrolment, patients will also undergo parallel assessment for cardiac involvement by PET/MRI.
Comparison of cardiac involvement identified by modified consensus criteria and PET/MRI will be performed.
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Completion of enrollment, an average of two years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The differences in circulating plasma biomarkers between cardiac with suspected cardiac sarcoidosis and healthy people
Time Frame: Completion of enrollment, an average of two years
|
A cohort of 25 healthy volunteers will be recruited for comparison of patients with suspected cardiac sarcoidosis.
Biomarkers such as microRNA will be analyzed in both groups.
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Completion of enrollment, an average of two years
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The prognostic significance of PET-MRI imaging findings in patients with cardiac inflammation
Time Frame: Through study completion, an average of three years
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Clinical follow-up to track adverse events to validate imaging findings and determine their prognostic significance.
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Through study completion, an average of three years
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-9933
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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