Non-Invasive Characterization in Cardiac Sarcoidosis

NCT02017522 | Terminated Results FDA Device

• 1 other identifier: HUM00079881
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Sarcoidosis

Keywords

PET; Cardiac sarcoidosis; FDG; Cardiac MRI

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour scan

Secondary Outcomes (1)

• The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis

  1 hour scan

Study Arms (1)

11C-PBR PET

EXPERIMENTAL

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.

Device: 11C-PBR PET

Interventions

11C-PBR PET DEVICE

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.

11C-PBR PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

• Title: Venkatesh Murthy, MD
• Organization: University of Michigan

vlmurthy@umich.edu

Study Officials

• Venkatesh L. Murthy, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects will have be injected 11C-PBR28, a compound used as a radiotracer. They will then have a PET CT scan.

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: April 4, 2014
• Primary Completion: July 7, 2015
• Study Completion: July 7, 2015
• Last Updated: August 1, 2018
• Results First Posted: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)