Clinical trial NCT02017522: Non-Invasive Characterization in Cardiac Sarcoidosis
Official title: Non-Invasive Characterization in Cardiac Sarcoidosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Sarcoidosis
Keywords: PET
Cardiac sarcoidosis
FDG
Cardiac MRI
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will have be injected 11C-PBR28, a compound used as a radiotracer. They will then have a PET CT scan.
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. must have undergone a cardiac positron emission tomography (PET) scan using 18F-fluorodeoxyglucose (FDG) for clinical reasons (i.e. referred by your doctor) within the preceding 30 days which showed evidence of active inflammation in your heart.

Exclusion Criteria:

1. 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. If you consent, a blood sample will be drawn to check whether you have this genetic variation.
2. Pregnancy or breastfeeding. If you are female and still experience menstrual periods, you must be willing to use contraception until your participation in the study is complete.
3. Allergy or intolerance to contrast dye containing gadolinium
4. Claustrophobia which would prevent you from completing an approximately one hour MRI scan
5. Inability to lie flat with your arms by your head
6. Abnormal kidney function (estimated GFR(glomerular filtration rate) \<60 ml/min/1.73 m2)
7. Implanted pacemaker, defibrillator or other medical devices which are not safe for 3 Tesla MRI
8. Metal in the eyes or shrapnel in the body
9. If you are clinically unstable you may not participate in this study. For example, if you have potentially life threatening abnormal heart rhythms which are not controlled by medication or other treatments, you cannot participate. Also, if you need medications to increase your blood pressure or cardiac function due to weak heart muscle, you cannot participate.

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Primary outcomes:
measure: Ratio of 11C-PBR28 in the Myocardium
timeFrame: 1 hour scan
Secondary outcomes:
measure: The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis
timeFrame: 1 hour scan
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Venkatesh L. Murthy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: