Non-Invasive Characterization in Cardiac Sarcoidosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Venkatesh L. Murthy, M.D., Ph.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT02017522
First received: December 16, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Cardiac Sarcoidosis
Device: 11C-PBR PET
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Non-Invasive Characterization in Cardiac Sarcoidosis

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Ratio of 11C-PBR28 in the myocardium [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The ratio of 11C-PBR28 PET activity in cardiac regions with fibrosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 8
Study Start Date: December 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 11C-PBR PET

Subjects will have a blood specimen drawn for the purpose of evaluating whether they have a specific genetic variation which would prevent the new type of imaging test we are evaluating from working properly. We will also test the inflammatory cells in the blood to compare to the imaging.

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 for you. 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.

Device: 11C-PBR PET

Subjects will undergo a positron emission tomography (PET) CT scan using 11C-PBR28 as the radiotracer. This study will evaluate areas of inflammation due to cardiac sarcoidosis. The CT scan will improve the images. The total scan time will be approximately 30 minutes. There will also be some time required for preparation before, such as inserting an intravenous (IV) catheter in an arm or forearm. Including preparation time, the 11C-PBR28 PET-CT scan will take approximately two hours.

Subjects will also undergo a cardiac MRI. Cardiac MRI uses strong magnetic fields to generate pictures of the heart. We will use gadolinium containing contrast material, given through an intravenous (IV) catheter in an arm or forearm to highlight areas of scar in your heart which may be due to cardiac sarcoidosis. This scan will take approximately 60 minutes.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017522

Contacts
Contact: Venkatesh L. Murthy, M.D. 734-936-5387 vmurthy@med.umich.edu
Contact: Jeffrey Meden, C.N.M.T. 734-936-5387 jmeden@med.umich.edu

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Venkatesh L. Murthy, M.D.    734-936-5387    vmurthy@med.umich.edu   
Contact: Jeffrey Meden, C.N.M.T.    734-936-5387    jmeden@med.umich.edu   
Principal Investigator: Venkatesh L. Murthy, M.D.         
Sub-Investigator: James R Corbett, MD         
Sub-Investigator: Eric S White, MD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Venkatesh L. Murthy, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Venkatesh L. Murthy, M.D., Ph.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02017522     History of Changes
Other Study ID Numbers: HUM00079881
Study First Received: December 16, 2013
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
PET
Cardiac sarcoidosis
FDG
Cardiac MRI

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014