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Non-Invasive Characterization in Cardiac Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02017522
Recruitment Status : Terminated (Poor initial results. Scans were of insufficient quality for study purpose.)
First Posted : December 20, 2013
Results First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Venkatesh L. Murthy, M.D., Ph.D., University of Michigan

Tracking Information
First Submitted Date  ICMJE December 16, 2013
First Posted Date  ICMJE December 20, 2013
Results First Submitted Date  ICMJE July 3, 2018
Results First Posted Date  ICMJE August 1, 2018
Last Update Posted Date August 1, 2018
Actual Study Start Date  ICMJE April 4, 2014
Actual Primary Completion Date July 7, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
Ratio of 11C-PBR28 in the Myocardium [ Time Frame: 1 hour scan ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
Ratio of 11C-PBR28 in the Myocardium [ Time Frame: 3 years ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis [ Time Frame: 1 hour scan ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis [ Time Frame: 3 years ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-Invasive Characterization in Cardiac Sarcoidosis
Official Title  ICMJE Non-Invasive Characterization in Cardiac Sarcoidosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Basic Science
Condition  ICMJE Cardiac Sarcoidosis
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: 11C-PBR PET

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: Device: 11C-PBR PET
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 3, 2018)
3
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2013)
8
Actual Study Completion Date  ICMJE July 7, 2015
Actual Primary Completion Date July 7, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02017522
Other Study ID Numbers  ICMJE HUM00079881
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Venkatesh L. Murthy, M.D., Ph.D., University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Venkatesh L. Murthy, M.D. University of Michigan
PRS Account University of Michigan
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP