Back to resultsNon-Invasive Characterization in Cardiac Sarcoidosis
Primary Purpose
Cardiac Sarcoidosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
11C-PBR PET
Sponsored by
About this trial
This is an interventional basic science trial for Cardiac Sarcoidosis focused on measuring PET, Cardiac sarcoidosis, FDG, Cardiac MRI
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- 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:
- 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.
- 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.
- Allergy or intolerance to contrast dye containing gadolinium
- Claustrophobia which would prevent you from completing an approximately one hour MRI scan
- Inability to lie flat with your arms by your head
- Abnormal kidney function (estimated GFR(glomerular filtration rate) <60 ml/min/1.73 m2)
- Implanted pacemaker, defibrillator or other medical devices which are not safe for 3 Tesla MRI
- Metal in the eyes or shrapnel in the body
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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Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
11C-PBR PET
Arm Description
Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test we are evaluating from working and we will test the inflammatory cells in the blood for the same purpose. 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. 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.
Outcomes
Primary Outcome Measures
Ratio of 11C-PBR28 in the Myocardium
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.
Secondary Outcome Measures
The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02017522
Brief Title
Non-Invasive Characterization in Cardiac Sarcoidosis
Official Title
Non-Invasive Characterization in Cardiac Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Poor initial results. Scans were of insufficient quality for study purpose.
Study Start Date
April 4, 2014 (Actual)
Primary Completion Date
July 7, 2015 (Actual)
Study Completion Date
July 7, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Sarcoidosis
Keywords
PET, Cardiac sarcoidosis, FDG, Cardiac MRI
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects will have be injected 11C-PBR28, a compound used as a radiotracer. They will then have a PET CT scan.
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
11C-PBR PET
Arm Type
Experimental
Arm Description
Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test we are evaluating from working and we will test the inflammatory cells in the blood for the same purpose.
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. 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.
Intervention Type
Device
Intervention Name(s)
11C-PBR PET
Intervention 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.
Primary Outcome Measure Information:
Title
Ratio of 11C-PBR28 in the Myocardium
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.
Time Frame
1 hour scan
Secondary Outcome Measure Information:
Title
The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis
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.
Time Frame
1 hour scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
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:
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.
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.
Allergy or intolerance to contrast dye containing gadolinium
Claustrophobia which would prevent you from completing an approximately one hour MRI scan
Inability to lie flat with your arms by your head
Abnormal kidney function (estimated GFR(glomerular filtration rate) <60 ml/min/1.73 m2)
Implanted pacemaker, defibrillator or other medical devices which are not safe for 3 Tesla MRI
Metal in the eyes or shrapnel in the body
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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Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venkatesh L. Murthy, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-Invasive Characterization in Cardiac Sarcoidosis
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