PET MRI Study in Patients With Cardiac Sarcoidosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03356756|
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : October 19, 2018
|Condition or disease||Intervention/treatment|
|Inflammatory Cardiomyopathy Sarcoidosis||Diagnostic Test: simultaneous combined 18F-FDG PET and cardiac MRI imaging|
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 :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Diagnostic and Prognostic Significance of Combined PET/MRI in Inflammatory Cardiomyopathies and Sarcoidosis|
|Actual Study Start Date :||June 27, 2016|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
PET MRI exam
simultaneous combined 18F-FDG PET and cardiac MRI imaging (PET MRI) performed immediately after the PET CT exam.
Diagnostic Test: simultaneous combined 18F-FDG PET and cardiac MRI imaging
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.
- 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 ]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.
- 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 15 healthy volunteers will be recruited for comparison of patients with suspected cardiac sarcoidosis. Biomarkers such as microRNA will be analyzed in both groups.
- The prognostic significance of PET-MRI imaging findings in patients with cardiac inflammation [ Time Frame: Through study completion, an average of three years ]Clinical follow-up to track adverse events to validate imaging findings and determine their prognostic significance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356756
|Contact: Kate Hanneman, MD||416-323-6400 ext 5521||Kate.Hanneman@uhn.ca|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Kate Hanneman, MD 416-323-6400 ext 5521 Kate.Hanneman@uhn.ca|
|Principal Investigator:||Kate Hanneman, MD||University Health Network, Toronto|