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Report for Clinical Trial NCT02017522

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Non-Invasive Characterization in Cardiac Sarcoidosis

In a study of Cardiac sarcoidosis, a serious heart condition, a radiotracer is being used to examine inflammation.

NCT02017522 Cardiac Sarcoidosis
MeSH:Sarcoidosis

1 Interventions

Name: 11C-PBR PET

Description: Subjects will have a positron emission tomography (PET) CT scan using 11C-PBR28 as a radiotracer. This study will evaluate inflammation due to cardiac sarcoidosis. The CT scan will improve the images. The total scan time will be about 30 minutes. There will also be some time required for prep, such as inserting an intravenous (IV) catheter in an arm or forearm. Including prep time, the scan will take approximately two hours. Subjects will also undergo a cardiac MRI. Cardiac MRI uses strong magnetic fields to make pictures of the heart. We will use gadolinium containing contrast material, given through an intravenous (IV) catheter to highlight areas of scar in your heart which may be due to cardiac sarcoidosis. This scan will take about 60 minutes.
Type: Device
Group Labels: 1

11C-PBR PET

Primary Outcomes

Description: 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 primary outcome is thus the intensity of uptake in abnormal regions as a percentage of the intensity of uptake in normal segments.

Measure: Ratio of 11C-PBR28 in the Myocardium

Time: 1 hour scan

Secondary Outcomes

Description: 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. This outcome will thus be expressed by 11C-PBR28 PET uptake in fibrotic regions as a percentage of uptake in normal segments We will also evaluate the concordance between extracardiac activity seen in 11C-PBR28 and FDG PET, and when available, histopathology of contemporaneous biopsy specimens.

Measure: The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis

Time: 1 hour scan
Purpose: Basic Science

Allocation: N/A

Single Group Assignment

There is one SNP

SNPs

1 rs6971

If you have two copies of a genetic variation called rs6971 which will prevent this tracer from generating high-quality images you may not participate.


HPO Nodes