Non-Invasive Characterization in Cardiac Sarcoidosis
Cardiac sarcoidosis is a serious medical condition which affects the heart. The purpose of this study is to characterize the relationship between the FDG PET findings and other markers of inflammation including using a new targeted PET radiotracer, 11C-PBR28, and analysis of blood specimens.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Non-Invasive Characterization in Cardiac Sarcoidosis|
- Ratio of 11C-PBR28 in the myocardium [ Time Frame: 3 years ] [ Designated as safety issue: No ]The primary outcome of this study will be the ratio of 11C-PBR28 PET activity in myocardial regions with inflammation indicated by FDG PET and/or edema indicated by increased T2 signal with cardiac MRI compared to the 11C-PBR28 PET activity in myocardial segments which appear normal on FDG PET and cardiac MRI.
- The ratio of 11C-PBR28 PET activity in cardiac regions with fibrosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]As a secondary outcome of this study we will evaluate the ratio of 11C-PBR28 PET activity in regions with fibrosis indicated by decreased myocardial perfusion on 82Rb PET and/or late gadolinium enhancement on cardiac MRI without imaging signs of active inflammation compared to 11C-PBR28 PET activity in myocardial segments which appear normal on 82Rb PET, FDG PET and cardiac MRI. We will also evaluate the concordance between extracardiac activity seen in 11C-PBR28 and FDG PET, and when available, histopathology of contemporaneous biopsy specimens.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: 11C-PBR PET
Subjects will have a blood specimen drawn for the purpose of evaluating whether they have a specific genetic variation which would prevent the new type of imaging test we are evaluating from working properly. We will also test the inflammatory cells in the blood to compare to the imaging.
All participants who proceed will have to return on at least one additional day to undergo a positron emission tomography (PET) scan similar to the scan your doctor ordered for you. we will use 11C-PBR28 as the radiotracer. This study will evaluate whether 11C-PBR28 can show areas of inflammation due to cardiac sarcoidosis. On either the same day or a different day, you will also undergo a cardiac MRI.
Device: 11C-PBR PET
Subjects will undergo a positron emission tomography (PET) CT scan using 11C-PBR28 as the radiotracer. This study will evaluate areas of inflammation due to cardiac sarcoidosis. The CT scan will improve the images. The total scan time will be approximately 30 minutes. There will also be some time required for preparation before, such as inserting an intravenous (IV) catheter in an arm or forearm. Including preparation time, the 11C-PBR28 PET-CT scan will take approximately two hours.
Subjects will also undergo a cardiac MRI. Cardiac MRI uses strong magnetic fields to generate pictures of the heart. We will use gadolinium containing contrast material, given through an intravenous (IV) catheter in an arm or forearm to highlight areas of scar in your heart which may be due to cardiac sarcoidosis. This scan will take approximately 60 minutes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02017522
|Contact: Venkatesh L. Murthy, M.D.||firstname.lastname@example.org|
|Contact: Jeffrey Meden, C.N.M.T.||email@example.com|
|United States, Michigan|
|University of Michigan Hospital||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Venkatesh L. Murthy, M.D. 734-936-5387 firstname.lastname@example.org|
|Contact: Jeffrey Meden, C.N.M.T. 734-936-5387 email@example.com|
|Principal Investigator: Venkatesh L. Murthy, M.D.|
|Sub-Investigator: James R Corbett, MD|
|Sub-Investigator: Eric S White, MD|
|Principal Investigator:||Venkatesh L. Murthy, M.D.||University of Michigan|