Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis
Primary Purpose
Cardiac Sarcoidosis
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hybrid PET/MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Sarcoidosis
Eligibility Criteria
Inclusion Criteria:
1.Subjects older than 18 years of age with high suspicion of cardiac sarcoidosis and/or biopsy proven extracardiac sarcoidosis and/or positive HRS criteria will be enrolled.
Exclusion Criteria:
- Coronary artery disease
- Insulin dependent diabetes
- Claustrophobia
- Pregnancy/nursing
- Presence of pacemaker or automatic implantable cardioverter-defibrillator
- Impaired renal function (estimated glomerular filtration rate <45 ml/min/1.73 m2) will be excluded.
- Inability to undergo PET/MRI due to any other condition.
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PET/MRI
Arm Description
Diagnostic testing with simultaneous PET/MRI for cardiac sarcoidosis diagnosis
Outcomes
Primary Outcome Measures
diagnosing cardiac sarcoidosis using combined 18F-FDG-PET/MRI examination
diagnostic accuracy of FDG-PET/MRI test will be determined by comparing the PET/MRI test against the Heart Rhythm Society (HRS) criteria which is the standard of reference.
Secondary Outcome Measures
Full Information
NCT ID
NCT03923049
First Posted
April 15, 2019
Last Updated
December 3, 2022
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03923049
Brief Title
Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis
Official Title
Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Suspended
Why Stopped
Lack of funding an support
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
April 5, 2050 (Anticipated)
Study Completion Date
April 5, 2050 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose and objectives of the study is to establish the feasibility of the simultaneous PET/MR in patients with cardiac sarcoidosis, determine relationships between various imaging biomarkers like extracellular volume (ECV) and standardized uptake values (SUV) from FDG-PET and to evaluate the diagnostic accuracy of the simultaneous method in comparison to the PET/CT and cardiac MRI.
Detailed Description
Patients who meet the inclusion criteria and agree to the study will be recruited from the Kirklin Clinic and UAB hospitals who will be undergoing FDG-PET/CT for cardiac study as part of their standard of care to diagnose cardiac sarcoidosis. MRI and FDG-PET screening questionnaire will be completed. A chart review will be completed to obtain data from patient medical records pertaining to study including age, gender, race, weight, height, vital signs, social and family history, past medical history especially if there is any history of hypertension, diabetes, high cholesterol levels, heart failure or history of lung diseases, lab results including brain natriuretic peptide levels, creatinine, hemoglobin, coagulation parameters, results of stress test/left heart catheterization, prior echocardiography if available. The CMR will be done solely for research purposes. The patient will be in the PET/MRI scanner for cardiac study only for 60-90 minutes, Finally, multi-sequence, multi-planar cardiac MR images will be acquired to assess cardiac chamber size, regional wall motion abnormalities, ejection fraction, left ventricular perfusion(using gadolinium-based agent) and late gadolinium enhancement.
The investigators will also conduct MRI examinations on 5 healthy volunteers to establish cardiac MRI protocol for the PET/MRI scanner. These scans will not involve any FDG administration to the healthy volunteers. These will involve cardiac MRI examinations to determine the feasibility and quality of MRI scans with the new scanner.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Sarcoidosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PET/MRI
Arm Type
Other
Arm Description
Diagnostic testing with simultaneous PET/MRI for cardiac sarcoidosis diagnosis
Intervention Type
Diagnostic Test
Intervention Name(s)
hybrid PET/MRI
Intervention Description
On the day of the procedure, subjects will undergo a PET scan followed by MRI scan.
Primary Outcome Measure Information:
Title
diagnosing cardiac sarcoidosis using combined 18F-FDG-PET/MRI examination
Description
diagnostic accuracy of FDG-PET/MRI test will be determined by comparing the PET/MRI test against the Heart Rhythm Society (HRS) criteria which is the standard of reference.
Time Frame
baseline through 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Subjects older than 18 years of age with high suspicion of cardiac sarcoidosis and/or biopsy proven extracardiac sarcoidosis and/or positive HRS criteria will be enrolled.
Exclusion Criteria:
Coronary artery disease
Insulin dependent diabetes
Claustrophobia
Pregnancy/nursing
Presence of pacemaker or automatic implantable cardioverter-defibrillator
Impaired renal function (estimated glomerular filtration rate <45 ml/min/1.73 m2) will be excluded.
Inability to undergo PET/MRI due to any other condition.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis
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