Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis

Cardiac Sarcoidosis Clinical Trial

Official title:

Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03923049
• Other study ID #: IRB-300002877
• Status: Terminated
• Phase: N/A
• Start date: May 21, 2019
• Est. completion date: December 2, 2020

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Coronary artery disease

2. Insulin dependent diabetes

3. Claustrophobia

4. Pregnancy/nursing

5. Presence of pacemaker or automatic implantable cardioverter-defibrillator

6. Impaired renal function (estimated glomerular filtration rate <45 ml/min/1.73 m2) will be excluded.

7. Inability to undergo PET/MRI due to any other condition.

Related Conditions & MeSH terms

• Cardiac Sarcoidosis
• Sarcoidosis

Intervention

Diagnostic Test:
• hybrid PET/MRI
On the day of the procedure, subjects will undergo a PET scan followed by MRI scan.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline through 24 hours