NCT02017522

Non-Invasive Characterization in Cardiac Sarcoidosis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Cardiac Sarcoidosis

Interventions

Type	Name	Description
DEVICE	11C-PBR PET	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.

Timeline

• Start date: 2014-04-04
• Primary completion: 2015-07-07
• Completion: 2015-07-07
• First posted: 2013-12-20
• Last updated: 2018-08-01
• Results posted: 2018-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study